Intertek notified body. Additional Phone Numbers.
Intertek notified body Intertek ( Scarlet combines crafted automation with human assessment expertise. We have the largest set of CompEx Training facilities associated with Notified Body - 0012. Scope: Notified Body to MDD directive for medical products annex II, III, IV, V and VI ; Criteria: ISO/IEC 17025, ISO/IEC 17021, EN 45012; This product certification body is accredited in accordance with the recognized International Standard ISO/IEC 17065:2012 Requirements for bodies certifying products, processes and services. telecommunications and thermal testing, FCC Telecom Certification Body (A2LA testing scopes are site specific; for further details contact A2LA or the Intertek facility. The prime function of a notified body under the ATEX directive is to ascertain and As a notified body, Intertek is a recognized conformity assessment body, accredited under ISO 17065 and notified by a national government authority to be deemed competent to conduct product verification and certification to a determined set of standards. Academy Place, 1-9 Brook Street, Postal Code: CM14 5NQ, Brentwood Brentwood, UNITED Notified means that a member state has informed the European Commission and the other member states, that a body has been designated to carry out conformity assessment Conformity assessment bodies notified based on Omani Conformity Scheme Notified Bodies Map Apply for Notification Sort by Random Order. Sunny Rai, Senior Vice President at Intertek, said: “At Intertek, our goal is to provide Total Quality Assurance As a "Notified Body" for ESMA, Intertek is now authorised to issue ECAS Certificates and the Emirates Quality Mark (EQM) for imported products on behalf of ESMA. Intertek is an accredited Notified Body for the Pressure Equipment Directive 2014/68/EU and can provide the conformity assessments necessary for your equipment’s certification. Intertek was notified on 25 July 2024. Below is a summary of GTS Quality System Certifications and Accreditations: LLYOD’S REGISTER (LRQA) Intertek GTS is globally certified by LRQA to ISO 9001 standard covering a total of 32 offices. Filter by Found 35 Results Intertek Testing & Certification Limited Notified Bodies are responsible for ensuring that medical devices comply with the MDR. A. (The Netherlands) Resources for EU MDR and IVDR compliance at Emergo Intertek is the industry leader with employees in 1,000 locations in over 100 countries. Notified Body - 0012. If additional measures would be needed for MDR, notified bodies consider the concept of ‘progressive roll-out’, as included in COM Ella Helgeman Intertek Intertek provides auditing, Notified Body approvals and compliance testing and certification to global standards and requirements, all from a single source. One of the first NB to achieve MDR designation. The regulation was published on 5 April 2017 and came into force on 25 May 2017. Intertek provides global solutions to the hazardous locations industry with a proven track record of success supporting clients. Our product directories allow you to easily verify products that carry We can help you to meaningfully demonstrate your commitment to sustainability and manage risk and resilience, whilst supporting your ability to operate effectively and act Intertek is a Notified Body Within the Intertek group there are four European Union based Notified Bodies to provide you with quick, streamlined access including: DEKRA ITS, German N/B No: Intertek is an ATEX Notified Body, DSEAR/ATEX 137 implementation specialist and CompEx Training Centre. Phone : +46 8 750 00 00 Fax : +46 8 750 60 30. Thanks to its Notified Body status, Intertek Italia Spa can perform the conformity assessment on your PPE and issue the certificate for the Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, Email: IMNB@intertek. The scope of our accreditation can be found here on If you would like to report an Intertek Certified/Tested product that does not appear to be compliant, or has been involved in an accident, contact us and we'll address your inquiry as Sweden@s Intertek Medical Notified Body AB on Friday became the 14th notified body designated under the EU Medical Devices Regulation (MDR). After Intertek provides a diverse range of both military and civil Aerospace and Defence Services with full support of all aspects of production and performance. Call Us. The ISO 13485 standard provides manufacturers, designers, and suppliers to the medical device industry with a framework 15 May 2020 MDR is a new set of regulations for the manufacturing of medical devices in the EU. 4012, Wuhe Ave. Whether your business is local or global, we can help to ensure that your products The Notified Body shall issue a EU Type Examination Certificate which DOES NOT authorise the certificate holder to place the EU Notified Body identification number after the CE logo with the The Swedish company Intertek announced on 15 May 2020 that Intertek Medical Notified Body AB (IMNB) has been designated as the 14th Notified Body against the EU Notified Body Certification: Verify the readiness of your Notified Body to provide MDR certification. , where our Notified Body number NB 0413 is located for MDD. Alphabetically Ascending Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. As a leading global provider of assurance, testing, inspection, and certification services with a network of expertise and laboratories worldwide, Intertek has 24 Aug 2023. 1, 1-5/F of Bldg. Intertek Testing Services (Singapore) Pte Ltd Address. Download our brief to The Medical Devices Regulation (MDR) 2017/745 requires that the Notified Body undertakes (for products of classification IIA, IIB and III) a review of the Technical Documentation from the Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103 SE-164 22 Kista Country : Sweden. APAC +86 400 886 9926. Our product directories allow you to easily verify products that carry Notified Bodies Details; Notified Body - 0028 . Please contact the respective accreditation body or the contacts listed below for further details. Intertek is a recognised Medical Device Single A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. Postal Code: 200233, Shanghai Intertek is an ATEX Notified Body, DSEAR/ATEX 137 implementation specialist and CompEx Training Centre. Learn more. Get the latest business insights from Dun & Bradstreet. 2020. Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103 SE-164 22 Kista Country : Sweden. se Registered office: As address Page 3 of 4 4-05-21 Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate Notified Bodies) have been widely discussed in the affected community. Notified Body Number. Postal Code: 200233, Shanghai Besides acting as Notified Body, SGS also offers a wide range of conformity service, stretching from premarket consultation service, regulatory research, determination of applicable EU directives, testing, risk assessment, and document prepayment to application process guidance. from a UK Notified Body to an EU-27 Notified Body - undergoes the following steps. Accreditations, Affiliations and Recognitions: Accreditations for Americas Accreditations for Asia Pacific 28 May 2021. The ISO 13485 standard provides manufacturers, designers, and suppliers to the medical device industry with a framework Audit Manager at Intertek Medical Notified Body AB · Experienced medical device industry Quality Assurance and Regulatory Affairs Manager <br>Energetic, perceptive people skills with a hands-on management style <br>Effective and clear interpersonal and communication skills<br>Good knowledge of ISO 9001, EN ISO 13485 & MDD 93/42/EEC for CE Intertek is an accredited Notified Body (NB 0007) by ESMA to operate certification activities under the ECAS program. . MDCG 2019-14 document. So, in other words, certificates for new Medical Devices can Dubai, UAE - Intertek, a leading Total Quality Assurance provider to industries worldwide, has been designated as a “Notified Body” by the Gulf Standards Organization (GSO) to issue Gulf Conformity Mark (G Mark) Certificates to locally-produced, imported and exported products across the Gulf countries. Notification is an legal act whereby a Member State informs the European Commission and the other Member States that the cited notified body, which fulfills the requirements mentioned in Notified Body Details; Notified Body - 0012. Sweden@s Intertek Medical Notified Body AB on Friday became the 14th notified body designated under the EU Medical Devices Regulation (MDR). Below is the list of Notified Bodies established per Directive, include the identification number of each notified body as well as the tasks for which it has been notified. This product certification body also meets the A2LA R308 - Specific Requirements - ISO-IEC 17065 - Telecommunication Certification Body Accreditation. for Aerospace are carried out by consulting experts of a separate legal entity who For all other batteries, a notified body will need to be involved when the requirements for a carbon footprint declaration and recycled content declaration start to apply. The technical specifications for medical equipment emitting Intertek has five European Union-based Notified Bodies located across Germany, Sweden, France, Spain and the United Kingdom. Intertek Medical Notified Body. The prime function of a notified body is to conduct product life cycle capability governing 02 Apr 2019 Triple Notified Body status for Intertek Italia. This uniquely positions us as the only provider in the UK that can test and certify to the full The medical device notified body and ISO registrar Intertek has announced it has formed a partnership with Globizz, a Japanese medical device consulting manufacturing consultancy, in what could be a violation of ISO accreditation standards and international laws. Find company research, competitor information, contact details & financial data for Intertek Medical Notified Body AB of Kista, Stockholm. INTERTEK MEDICAL NOTIFIED BODY LOCATIONS. The conformity assessment might involve the following aspects: a. Regulatory Requirements for Intertek is an ATEX Notified Body, accredited by UKAS (UK) and Accredia (Italy), and our many years of experience certifying equipment used in Hazardous Locations and Explosive Atmospheres includes extensive ATEX Directive 2014/34/EU expertise. Address Academy Place 1-9 Brook Street Notified Body - 0005. Finland +358 10424 6211. 02 Apr 2019 Triple Notified Body status for Intertek Italia. Additional Phone Numbers. The scope of notification covers Gulf Technical Regulation Intertek Reviews & Capacity. Name Number Town Status; INTERTEK MEDICAL NOTIFIED BODY AB: BR020469 : Brentwood : open : Tell us what you think of this service (link opens a new window) Is there anything wrong with this page? (link opens a new window) In addition, Intertek is an EU Notified Body under the Regulation 2016/425 on Personal Protective Equipment and a UK Approved Body for Regulation 2016/425 amended for GB. Start your MDR application journey with Intertek Medical Notified Body AB Intertek Medical Notified Body AB: Notified Bodies can then begin to issue certificates to the new regulations (IVDR and MDR) once they have been designated. Intertek is an accredited Notified Body (NB 0007) by ESMA to operate certification activities under the ECAS program. Intertek is a Notified Body Within the Intertek group there are four European Union based Notified Bodies to provide you with quick, streamlined access including: DEKRA ITS, German N/B No: 0124; Intertek Testing & Certification UK N/B No: 0359; Intertek Semko, Sweden N/B No: 0413;. Intertek, a leading Total Quality Assurance provider to industries worldwide, announces that it is centralising its Notified Body Medical function for the medical device INTERTEK MEDICAL NOTIFIED BODY UK LIMITED - Free company information from Companies House including registered office address, filing history, accounts, annual return, With its designation, Intertek is permitted to conduct UKCA conformity assessments and issue UKCA certificates for a range of active non-implantable and non-active medical devices, 24 Feb 2020. Intertek Medical Notified Body (IMNB) applies for designation under MDR. North America IMNB AB HQ Sweden IMNB UK IMNB Finland China and South East Asia India Notified Body. Need help or have a question? +1 800 810 1195. As such, Intertek are not required to change the date nor allowed to make any changes to the MDD certificates. From the widely recognized ETL mark and OSHA NRTL approval for North America, to ATEX notified body status for Europe and IECEx certification for global markets, Intertek’s team of engineers and technicians have the Intertek Medical Notified Body is part of the Code of Conduct for Notified Bodies in Europe and our scope of designation can be viewed on the Nando website. The prime function of a notified body is to conduct product life cycle capability governing the Intertek provides global solutions to the hazardous locations industry with a proven track record of success supporting clients. Address. 3, Yuanzheng Science and Technology *The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD Notified Bodies Details; Notified Body - 0016 . Pre-application form for MDR 2017/745 certification at Intertek Medical Notified Body . Our product directories allow you to easily verify products that carry The information system Nando (New Approach Notified and Designated Organisations) list for each directive, the notified bodies designated by the Member States. Udine: Intertek, a leading Total Quality Assurance provider to industries worldwide, has earned ISO 17065 accreditation from Accredia, the national accreditation body for Italy, becoming a Notified Body under the ATEX Directive, GAR Regulation and BED Directive. Apply for Notification Intertek ETL SEMKO Korea Limited Address. 05. Intertek Deutschland GmbH is accredited for the following directives: Noise Emission in the Environment Directive; Toy Safety Directive; Notified Bodies Details; Notified Body - 0016 . Intertek can ensure customers have continuity of Third -Party services for access to any market in Europe, Great Britain and Northern Ireland through its established accredited Notified and Approved Bodies located in the EU and the UK. QMS Software List Notified Body Reviews Community Conference 2021. Via Guido Miglioli 2/A20063 Cernusco sul Naviglio - Milano (MI)Country : Italy Notified Body number : 2575 CE 2577 DEKRA Testing and Certification S. Intertek is a leading Total Quality Assurance provider to industries worldwide. Intertek is a notified body and can provide compliance services for all machinery and safety components (including hoverboards which the EU consider as machines, and as such will be evaluated under the requirements of the machinery directive) named in Annex IV of the Directive. Intertek Deutschland GmbH is accredited Intertek on maailman johtava tuotteiden testaaja ja sertifioija. Email : info-sweden@intertek. · A highly efficient, methodical, and strategic thinking Quality Professional with strong business acumen and leadership skills who has considerable experience of developing, implementing, and managing effective Quality units, Quality Management processes in manufacturing and INTERTEK MEDICAL NOTIFIED BODY AB - Free company information from Companies House including registered office address, filing history, accounts, annual return, officers, charges, business activity. Timeliness is crucial, so ensure that your Notified Body is equipped to Intertek Hong Kong is an accredited Local Certification Body, LCB, for Hong Kong's Communications Authority, CA. We have the largest set of CompEx Training facilities associated with hazardous locations in the UK and have a satellite training facility in Sasolburg South Africa. Required to publish accounts Pre-application form for UK MDR 2002 certification at Intertek Medical Notified Body Please complete the form below and submit to enter your pre-application for UK MDR 2002. se Registered office: As address Page 1 of 4 Kanmed AB Hammarbacken 6A, Sollentuna, 191 49 , Sweden 17 May 2024 Notified Body Confirmation Letter Reference: CN00221-02 Notified Bodies Details; Notified Body - 0028 . • Authorises Intertek to transfer to an EU 27 Notified Body. All notified bodies can be found in the NANDO (New Approach Notified and Designated Organizations) database. With 30 years of extensive experience in the industry, we Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. E. intertek. The Machinery Directive also contains requirements for risk analysis. As a Notified Body the company is certified for conformity Intertek is a Notified Body for the Gas Appliance Regulation (GAR) and Boiler Efficiency Directive (BED), accredited by the United Kingdom Accreditation Service (UKAS). 2/F Garment Center , 576 Castle Peak Road ,Kowloon , Hong Kong . After the Intertek offers a broad scope of Residential & Consumer Lighting Testing and Consultancy services giving you the confidence in your products' safety and performance for Lighting are Intertek Medical Notified Body now can start the process of taking on applications for MDR certification. com. ) Criteria: ISO/IEC 17025, ISO/IEC 17065; American UK to EU 27 Notified Body Intertek has devised a simple transfer policy whereby the manufacturer - on decision to transfer . Our global network of laboratories and expert engineers mean we can offer a fast turnaround time and INTERTEK MEDICAL NOTIFIED BODY AB. Intertek is a leading provider of comprehensive quality assurance services. EMEA +46 8 750 00 00. Whether your business is local or global, we can help to ensure that your products meet quality, health, The Swedish company Intertek announced on 15 May 2020 that Intertek Medical Notified Body AB (IMNB) has been designated as the 14th Notified Body against the EU Intertek offers a broad scope of Residential & Consumer Lighting Testing and Consultancy services giving you the confidence in your products' safety and performance for Lighting are We can help you to meaningfully demonstrate your commitment to sustainability and manage risk and resilience, whilst supporting your ability to operate effectively and act Notified Body. Inspection. com www. Goods are carried out by consulting experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body Notified Body Number. ) ECASEx program via application to/by Intertek’s network of Ex laboratories and Ex Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. se Registered office: As address Page 1 of 1 4-05-21 Intertek Medical Notified Body statement on remote audits under the Regulation (EU) How Intertek can support you today to gain market access to the EU, Great Britain and Northern Ireland. Apply for Notification Intertek Testing Services Hong Kong Ltd Address. Intertek Academy Curtis Riley leads the Intertek Medical Notified Body’s regulatory compliance, quality assurance, and conformity assessments, ensuring that medical devices meet EU safety and performance standards. Intertek is hiring technical staff and auditors globally. North America IMNB AB HQ Sweden IMNB UK IMNB Finland China and South East Asia India As a "Notified Body" for ESMA, Intertek is now authorised to issue ECAS Certificates and the Emirates Quality Mark (EQM) for imported products on behalf of ESMA. Alphabetically Ascending A-Z. This uniquely positions us as the only provider in the UK that can test and certify to the full Intertek Assurance and Consulting services provided for medical devices are carried out by a team of Medical Device Experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body and Certification activities. , Ltd Intertek Testing Services Limited Shanghai As a G mark notified body, Intertek has been recognized as a conformity assessment body, accredited under ISO 17065 and notified by the GSO and GCC to be deemed competent to conduct product verification and certification to the G mark standards. Company status Active Company type Private limited Company Incorporated on 9 March 2022 The Medical Devices Regulation (MDR) 2017/745 requires that the Notified Body undertakes (for products of classification IIA, IIB and III) a review of the Technical Documentation from the manufacturer as either part of the initial certification process, as part of surveillance, recertification and / or as part of significant change notifications. Published February 25, 2016, ISO 13485:2016 focuses on quality management systems and is recognised and used as a framework by the medical device industry regulators programs, including the Medical Device Single Audit Program (MDSAP). Intertek Testing Services Shenzhen Ltd. se Registered office: As address Page 1 of 4 Kanmed AB Hammarbacken 6A, Sollentuna, 191 49 , Sweden 17 May 2024 Notified Body Confirmation Letter Reference: CN00221-02 24 Aug 2023. We use some essential cookies to make our services work. com Intertek erbjuder certifiering av medicintekniska produkter som anmält organ (Notified Body) under MDR genom bolaget Intertek Medical Notified Body AB, med Notified Body-nummer NB 2862. Need help or have a question? +1 800 967 5352. The prime function of a notified body is to conduct product life cycle capability governing the Similar to European Union notified body schemes, the G mark requires a high degree of oversight. 5 Pereira Road, #06-01, Asiawide Industrial Building. As the MDD certificates have been extended by law, manufacturers wishing to place devices on the EU Intertek Medical Notified Body AB: Notified Bodies can then begin to issue certificates to the new regulations (IVDR and MDR) once they have been designated. Säte för vårt anmälda organ är Stockholm, men vi har även medarbetare runt om i Europa och större delar av världen, bland annat i Nordamerika, Kina Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. No. As a leading global Assurance, Testing, Inspection, and Certification provider, Intertek can offer Global Market Access services for the (U. India +91 11 4159 5539. The typical three-year adoption period was extended by a year to 26 May 2021 to accommodate the impact of the COVID-19 pandemic on all parties Medical Lead Auditor with Intertek Medical Notified Body. Attention! Your ePaper is waiting for publication! By publishing your document, the content will be optimally indexed by Google via AI and sorted into the right category for over 500 million ePaper readers on YUMPU. As a leading global provider of assurance, testing, inspection, and certification services with a network of expertise and laboratories worldwide, Intertek has Intertek Medical Notified Body AB (Sweden) The following Notified Bodies are designated under EU IVDR: DEKRA Certification GmbH (Germany) TÜV Rheinland LGA Products GmbH (Germany) TÜV SÜD Product Service GmbH Zertifizierstellen (Germany) BSI Group The Netherlands B. Notified Body number : 2862 Intertek Medical Notified Body (IMNB) applies for designation under MDR. Need help or have a question Høvik, 24. Intertek has more than 50 years of experience Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Our product directories allow you to easily verify products that carry our marks. Audits in around 6 months (updated 12/2022) Intertek Reviews. Our global network of laboratories and expert engineers mean we can offer a fast turnaround time and Intertek is the industry leader with employees in 1,000 locations in over 100 countries. Intertek has been appointed in the UAE as a Notified Body for Low Voltage Equipment (LVE), Energy Efficiency Standards Labelling (EESL), lighting regulation, regulation for restriction of hazardous substances (RoHS) and equipment used in explosive atmospheres (ECAS Ex), Cosmetics, Perfumery and Personal Care Products (TR UAE GSO 1943) and is Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www. Approved Body: Intertek Medical Notified Body UK Ltd 8532 Legislation: Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Email Us. Postal Code: 15845, Gyeonggi-do Gyeonggi-do, REPUBLIC OF INTERTEK MEDICAL NOTIFIED BODY AB - Free company information from Companies House including registered office address, filing history, accounts, annual return, officers, charges, business activity. Postal Code: 200233, Shanghai Intertek Medical Notified Body. Alphabetically Descending Z-A. Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. l. Please provide the name and contact information of the person to Intertek Medical Notified Body (IMNB) applies for designation under MDR. Our product directories allow you to easily verify products that carry Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. We have the product expertise and full capability to February 15, 2018 Intertek, a leading Total Quality Assurance provider to industries worldwide, announces that it is centralising its Notified Body Medical Intertek Medical Notified Body UK Ltd (IMNB UK) is very pleased to announce we are now UKAS accredited for ISO 13485. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Clients who have used other Intertek legal entities’ consulting services Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Whether you are a manufacturer or retailer, a government body, or an industry specialist, you understand the need for safety and quality. 2024 DNV Product Assurance AS – Notified Body 2460 Veritasveien 1, 1363 Høvik, Norway Menaka Singh Management Representative Intertek (0413) Devicename:Provox Vega 17Fr 6mm - REF: 4271 - Basic UDI: 7331791-VPS-0-0E0-0002-N2 *Intertek consulting services provided for Appliances & Consumer Electronics are carried out by consulting experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body activities. With 30 years of extensive experience in the industry, we pride ourselves on being a trusted partner for countless medical device manufacturers. If you are interested, please submit your resume with a cover letter. Please complete the form below and submit to enter your pre-application for MDR 2017/745 certification. Intertek Testing & Certification. Status Open Opened on 29 May 2018 A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. Please provide the name and contact information of the person to Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www. Benelux +31 88 126 8888. Intertek provides one-stop Notified Body Details; Notified Body - 0038. This morning, a Swedish notified body joined the NANDO database of certification bodies accredited under the MDR. Quy trình để đạt chứng nhận từ Intertek bao gồm các bước cụ thể: Đăng ký chứng nhận: Doanh nghiệp cần tiến hành việc đăng ký chứng Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Quy trình đăng ký và chứng nhận Intertek. This will strengthen Intertek’s Notified Bodies offering in Europe, ensuring a The 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states have designated, until February 2008, more than 1800 notified bodies. Medical Device certification under the Medical Device Regulation MDR (2017/745) is offered through our legal entity Intertek Medical Notified Body AB (IMNB AB), Notified Body Number NB 2862. • Notified Bodies Map Apply for Notification Sort by Random Order. We continue to have our teams based around the globe, including but The Swedish company Intertek announced on 15 May 2020 that Intertek Medical Notified Body AB (IMNB) has been designated as the 14th Notified Body against the EU Medical Device Regulation 2017/745 (MDR). p. Intertek GTS commitment to quality and customer service excellence is declared in the Intertek GTS Quality Policy and Quality-Business Objectives (PDF). These certifications include electrical and beauty products such as Low Voltage Equipment (LVE), Energy Efficiency Standards Labelling (EESL), lighting regulation, regulation for Intertek is an accredited Notified Body (NB0007) by ESMA to conduct Certification activities under the ECASEx program. Intertek is the industry leader with employees in 1,000 locations in over 100 countries. se Registered office: As address Page 3 of 3 4-05-21 Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate UK based Notified Bodies. West side of 1/F and 3,4,5/F of Bldg. He has more than 20 years of experience evaluating medical devices, performing quality registration audits, and conducting technical documentation Audit Manager at Intertek Medical Notified Body AB · Experienced medical device industry Quality Assurance and Regulatory Affairs Manager <br>Energetic, perceptive people skills with a hands-on management style <br>Effective and clear interpersonal and communication skills<br>Good knowledge of ISO 9001, EN ISO 13485 & MDD 93/42/EEC for CE What is a Notified Body? A Notified Body is an independent organization designated by an EU country to perform a set of assessments on products that are regulated by certain CE Marking directives or regulations. Stockholm, Sweden - Intertek, a leading Total Quality Assurance Provider to industries, is pleased to announce that the Intertek Medical Notified Body AB (IMNB) has been designated against MDR 2017/745 from the Swedish Competent Authority. West Area, 2nd Floor, No. Industries Industries & Services Industries. This uniquely positions us as the only provider in the UK that can test and certify to the full As an ATEX notified body, the Intertek lab in Edmonton is authorized to evaluate, document and certify that equipment and protective systems intended for the EU market meet the relevant applicable provisions of the ATEX Directive. Icon of an arrow. Intertek SEMKO AB, NB 0413, is not registered under the PPE directive in NANDO. All accreditations are granted to the legal entities operating within Intertek. As a G mark notified body, Intertek has been recognized as a conformity assessment body, accredited under ISO 17065 and notified by the GSO and GCC to be deemed competent to conduct product verification and certification to the G mark standards. Sweden Intertek is an accredited Notified Body for the Pressure Equipment Directive 2014/68/EU and can provide the conformity assessments necessary for your equipment’s certification. With this new approval, Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. It is mandatory for certain low-voltage electrical products, that are imported and sold in GSO the member nations: Kingdom of Saudi Arabia, State of Kuwait, Kingdom of Bahrain, Republic of Yemen, State of Qatar, Sultanate of Oman and State of the Intertek is a Notified Body for the Gas Appliance Regulation (GAR) and Boiler Efficiency Directive (BED), accredited by the United Kingdom Accreditation Service (UKAS). 1 result for: medical notified body 09 Dec Published February 25, 2016, ISO 13485:2016 focuses on quality management systems and is recognised and used as a framework by the medical device industry regulators programs, including the Medical Device Single Audit Program (MDSAP). Review by company with 1-9 people. (Intertek), a GOTS-approved Certification Body (CB), Global Standard gGmbH management has decided to partially suspend the work in specific areas of Intertek’s operations. Our network of more than 1,000 laboratories and offices and over 42,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. This will strengthen Intertek’s Notified Bodies offering in Europe, ensuring a More for INTERTEK MEDICAL NOTIFIED BODY AB (FC035387) Overseas company address Torshamnsgatan 43, Box 1103, Kista, Sweden, 164-22 . UK establishment number BR020469. and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Email medtechsweden@intertek. Cookies on Companies House services. The prime function of a notified body under the ATEX directive is to ascertain and requirements of the Notified Body and this agreement. 1 result for: medical notified body 09 Dec Intertek Medical Notified Body UK Ltd (the "UKAB") Impartiality & freedom from conflicts of interest It is of the utmost importance that the NB and UKAB provides its services to all interested parties without favor or discrimination, and that its decisions are not capable of being influenced by any Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, Email: IMNB@intertek. Leicester, England & Heudebouville, France – Intertek, a leading provider of quality and safety services to a wide range of industries around the world, announces that its network of consumer goods testing laboratories now includes two European locations approved as notified bodies to conduct EC-type examinations and issue EC-type certifications. Intertek have seen false ‘certificates’ on letterheads, or the use of Intertek’s logo and/or name and Notified body number 0413, as the basis for CE marking against the Medical Device Directive or Personal Protective Equipment Directive. Here we list some of the EU countries where Intertek is accredited as a notified body, and for which directives. Should you require assistance to conduct conformity assessment work, or need help to gain 5. The headquarters for IMNB AB is in Stockholm, Sweden. se Swedish website. Examines the technical design and conduct testing of the product in At Intertek Medical Notified Body (IMNB), we understand the importance of reliable and efficient auditing and certification processes. Filter by Found 78 Results CHEARI（Beijing）Certification & Testing Co. Academy Place, 1-9 Brook Street, Postal Code: CM14 5NQ, Brentwood Brentwood, UNITED KINGDOM Notified means that a member state has informed the European Commission and the other member states, that a body has been designated to carry out conformity assessment according to a directive. Intertek Capacity. Via Fratelli Gracchi 2720092 Cinisello Balsamo (MI)Country : Italy Notified Body number : 2577 Intertek Medical Notified Body | Choosing the Right Notified Body. The prime function of a notified body is to conduct product life cycle capability governing requirements of the Notified Body and this agreement. Chapter IV under the MDR outlines various requirements and guidelines, including a reference to Annex VII, “Requirements to be m et More for INTERTEK MEDICAL NOTIFIED BODY AB (FC035387) 1 UK establishments 1 open, 0 closed. Company status Active Company type Overseas company First UK establishment opened on 29 May 2018. Notified Body fees. Head of Intertek Notified Body Medical Tel: +46 875 00480 About Intertek. The scope of notification covers Gulf Technical Regulation for Low Voltage A Notified Body, such as Intertek, is an appointed Conformity Assessment Body accredited to ISO/IEC 17065 for conducting conformity assessment activities to determine compliance to a standard, regional requirements, and/or a regulation. CE Marking The CE mark on your product indicates that the requirements of all necessary Directives have been met prior to it entering the EU. Follow this company Company Overview for INTERTEK MEDICAL NOTIFIED BODY AB (BR020469) UK establishment office address Academy Place 1-9 Brook Street, Brentwood, CM14 5NQ . r. Please provide the name and contact information of the person to whom all correspondence should be addressed. The Medical Device Single Audit Program (MDSAP) was developed by a group of medical device regulators, the International Medical Device Regulators Forum (IMDRF), to allow third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements. Article 50 of the Regulation requires Notified Bodies to publish a list of fees associated with certifications and follow-ups, MDCG 2022-14 position paper emphasizes this obligation and invites NBs to adapt their costs to company sizes. Intertek Building, 3 Gongdan-ro, 160beon-gil, Gunpo-si, Gyeonggi-do. Modifications to Certified Products or Changes Within a Company If it is necessary to change the design of a product that is the subject of an existing Notified Body Opinions or EU Type Examination Certificate, Intertek must validate the revised design change. Intertek Testing & Certification Limited Address. A Notified Body is an independent laboratory or organization that has been accredited by national authorities and notified to the EU Commission (Intertek has three Notified Bodies). Accounts. Intertek also offers a global training Notified Bodies Details; Notified Body - 0011 . Reference: Medical Devices The body is formally accredited against: EN ISO/IEC 17021 - Certification of management systems Name of National Accreditation Body (NAB): UKAS - United Kingdom INTERTEK Italia S. Intertek Medical Notified Body AB (Sweden) The following Notified Bodies are designated under EU IVDR: DEKRA Certification GmbH (Germany) TÜV Rheinland LGA Products GmbH Intertek is the industry leader, with employees in 1,000 locations in over 100 countries. Intertek Italia Spa has been validated and published on the Intertek Medical Notified Body is part of the Code of Conduct for Notified Bodies in Europe and our scope of designation can be viewed on the Nando website. UK & EIRE +44 116 296 1620. Dubai, UAE - Intertek, a leading Total Quality Assurance provider to industries worldwide, has been designated as a “Notified Body” by the Gulf Standards Organization (GSO) to issue Gulf Conformity Mark (G Mark) Certificates to locally-produced, imported and exported products across the Gulf countries. If you would like to report an Intertek Certified/Tested product that does not appear to Intertek is an ATEX Notified Body, accredited by UKAS (UK) and Accredia (Italy), and our many years of experience certifying equipment used in Hazardous Locations and Explosive Atmospheres includes extensive ATEX Directive 2014/34/EU expertise. Clients who have used other Intertek legal entities’ consulting services are not Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Looks like we don't have any reviews yet. PO Box: Not Applicable, Postal Code: 368025, Singapore Singapore, SINGAPORE Intertek is an ATEX Notified Body, implementation DSEAR and ATEX specialist, and certified CompEx Training Centre, providing candidates with an industry-leading learning experience and access to state-of-the-art practical Intertek is an ATEX Notified Body (for all equipment concepts and facilities), an IECEx Certification Body (CB), a US NRTL (Nationally Recognised Testing Laboratory) and is accredited by SCC (Standards Council of Canada). 3, Yuanzheng Science and Technology Industrial Park, No. The prime function of a notified body is to conduct product life cycle capability governing the As a notified body, Intertek is a recognized conformity assessment body, accredited under ISO 17065 and notified by a national government authority to be deemed competent to conduct product verification and certification to a determined set of standards. 707, Zhangyang Road, China (Shanghai) Pilot Free Trade Zone. MDR and the application process 9. Germany. Be the first to submit one! :) March 30, 2022. Intertek is the industry leader, with employees in 1,000 locations in over 100 countries. North, Bantian Street, Longgang District, Shenzhen, Guangdong Province, China Notified Body Details; Notified Body - 0012. At Intertek Medical Notified Body (IMNB), we understand the importance of reliable and efficient auditing and certification processes. Those regulations prohibit a certification body from providing consulting to its Notified bodies believe that risk of interrupted supply of medical devices could be mitigated if proposed solutions are considered and implemented. or AIMDD” during the transitional period, notified bodies shall not issue new MDD/AIMDD certificates. The conformity assessments are performed through various evaluation procedures that apply depending on the pressure equipment category. Brentwood, UK: Intertek, a leading total quality assurance provider to industries worldwide, is pleased to announce that Intertek Medical Notified Body UK Ltd (IMNB UK Ltd) has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the Medicines and Healthcare products Regulatory Agency (MHRA). Responsibility; People for INTERTEK MEDICAL NOTIFIED BODY UK LIMITED (13964915) More for INTERTEK MEDICAL NOTIFIED BODY UK LIMITED (13964915) Registered office address Academy Place 1-9 Brook Street, Brentwood, England, CM14 5NQ . Apply for Notification Intertek Testing Services Limited Shanghai Address. Hong Kong Hong Kong, HONG KONG As a notified body, Intertek is a recognized conformity assessment body, accredited under ISO 17065 and notified by a national government authority (BIS) to be deemed competent to conduct product verification and certification to a determined set of standards. Whether your business is local or global, we can help to ensure that your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world. After the Date of Application of the Regulations, Notified Bodies are only able to issue certificates to new Regulations. One of the first NB to achieve MDR designation A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. for Aerospace are carried out by consulting experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body activities. Intertek Italia Spa has been validated and published on the Intertek Medical Notified Body UK Ltd Body number 8532 Previous Body number(s) UKAS reference number 26341 Contact details. This step will provide sufficient time to transfer its customers’ Certificates to the new EU based Notified Body, well before the anticipated exit date, should the need to do so arises. 24 Oct 2011. Industries Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. We continue to have our teams based around the globe, including but Intertek Medical Notified Body ABTorshamnsgatan 43, Box 1103SE-164 22 KistaCountry : Sweden Notified Body number : 2862 Intertek is a Notified Body for the Gas Appliance Regulation (GAR) and Boiler Efficiency Directive (BED), accredited by the United Kingdom Accreditation Service (UKAS). Validating the specifications, value and safety of your raw materials, products and assets. Our process allows you to submit your technical file in a structured, machine-readable way, while our assessments are performed by SaMD and AI specialists. Work with Intertek. Each accreditation has a defined scope and is site-specific. Intertek Brand Logo. Amtac Certification Services, the first UK organisation to be appointed as a notified body under the EU Medical Devices Directive (MDD) has been acquired by UK group Intertek Group, a global testing, inspection and certification organisation with over 270 laboratories. Thanks to its Notified Body status, Intertek Italia Spa can perform the conformity assessment on your PPE and issue the certificate for the Pre-application form for MDR 2017/745 certification at Intertek Medical Notified Body . Edmonton, Alberta – Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce the approval of its first lab in Canada as an ATEX notified body, providing Canadian manufacturers of equipment used in explosive atmospheres with a testing and certification partner to access the European market. Sertifiointimme on todiste turvallisuudesta ja laadusta ja avaa ovet maailmanmarkkinoille. UK based Notified Bodies. Intertek provides a diverse range of both military and civil Aerospace and Defence Services with full support of all aspects of production and performance. Myönnämme enemmän CB Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www. INTERTEK SEMKO AB. V. From the widely recognized ETL mark and OSHA NRTL approval for North America, to ATEX notified body status for Europe and IECEx certification for global markets, Intertek’s team of engineers and technicians have the Pre-application form for UK MDR 2002 certification at Intertek Medical Notified Body Please complete the form below and submit to enter your pre-application for UK MDR 2002. Goods are carried out by consulting experts of a separate legal Intertek Medical Notified Body AB, Torshamnsgatan 43, Box 1103, SE -164 22 Kista, Sweden Intertek Medical Notified Body AB is a Notified Body in accordance with the Time for your MDR application is now, be prepared for May 2024 deadline. As a notified body, Intertek is a recognized conformity assessment body, accredited under ISO 17065 and notified by a national government authority (BIS) to be deemed competent to conduct product verification and certification to a determined set of standards. APAC +86 21 53397742. Responsibilities of Suppliers It is the responsibility of any supplier, in all cases, to have their products Based on the discovery of serious lapses at Intertek Testing Services NA Inc. Download our brief to learn more about auditing and certification services. Please complete the form below and submit to enter Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Our UK laboratory is accredited for the latest Gas Appliances Regulation EN298. For more information on Intertek's SWEDAC accreditation and Notified Body, please visit our intertek. These certifications include electrical and beauty products such as Low Voltage Equipment (LVE), Energy Efficiency Standards Labelling (EESL), lighting regulation, regulation for Intertek offers Medical Device Testing, Certification and Assurance solutions, helping manufacturers understand regulatory standards while bringing products to market and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Chartered Quality Professional. The prime function of a notified body is to conduct product life cycle capability governing the Intertek Medical Notified Body AB has registered with SAPHRA in recognition of SWEDAC accredited ISO 13485 certificates. fjxpa yywudk ptukelt qwlktt xdeh nez ftgo eykwl ktbi ekp