INTERTEK ITALIA SPA
Feb 03, 2021 · TL-451 INTERTEK ITALIA S P A Page 3 of 15 CONSOLIDATED VERSION IEC 60601-1-8 Edition 2 1 2012-11 Medical electrical equipment – Part 1-8: General requirements for basic safety
510(k) Summary K t &2 Teratech Corporation
Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems o Intertek Project: 9157933B0X-002B * IEC60601-1-4 (2000), Collateral Standard: Safety Requirements for Medical Electrical Systems o Intertek Project: 9157933B0X-003B * lEG 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2:
SMITHS MEDICAL INTERNATIONAL LIMITED
requirements of the Notified Body AMTAC Certification Services Limited is a Notified Body according to Directive 93/42/EEC for medical devices, with identification number 0473 EC Certification FULL QUALITY ASSURANCE SYSTEM Directive 93/42/EEC for Medical Devices, Annex II excluding (4)
Nissha Medical Technologies, Vermed,
Intertek Certification AB P O Box 1103, SE-164 22 Kista, Sweden This is to certify that the management system of: Graphic Controls d b a Nissha Medical Technologies, Vermed, Biomedical Innovations Main site: 400 Exchange St, Buffalo, New York 14204, United States has been registered by Intertek as conforming to the requirements of
Initial Certification Date: Graphic Controls dba Nissha
Medical Technologies, Vermed, Biomedical Innovations (FIN F000831) Main Site: 400 Exchange Street, Buffalo, New York, 14204, USA has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of: ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1
This is to certify that the quality management system of
EaglePicher Medical Power, LLC & EaglePicher Energy Products Corporation Divisions of EaglePicher Technologies, LLC Main Site: EaglePicher Technologies, LLC 8230 East 23rd Street Joplin, Missouri, 64804 USA Additional sites: Refer to Appendix has been assessed by Intertek as conforming to the requirements of: ISO 13485:2016
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This is to certify that the management system of:
Graphic Controls d.b.a. Nissha
Medical Technologies, Vermed,
Biomedical Innovations
(F000831) Main Site: 400 Exchange Street, Buffalo, New York, 14204, USA has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of:ISO 13485:2016
Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excludingPart 1.6);
Brazil: Federal Law n. 6360/76; RDC ANVISA n. 16/2013; RDC ANVISA n. 23/2012;RDC ANVISA n. 67/2009; RDC ANVISA n. 56/2001
Canada: Medical Devices Regulations ʹ Part 1- SOR 98/282 Japan: MHLW Ministerial Ordinance 169, Article 4 to Article 68, PMD Act (as applicable) United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)The management system is applicable to:
The design, development, and manufacture of medical recording charts, leadwires, ECG electrode families. Design of defibrillator pads.
Certificate Number:
0085640-03
Initial Certification Date:
2018-12-30
Date of Certification Decision:
2022-01
-05Certification Effective Date:
2022-01-05
Certification Expiry Date:
2024-12-29
Calin Moldovean
President, Business Assurance
Intertek Testing Services NA, Inc.
900 Chelmsford Street
Lowell, MA, USA 01851
In the issuance of this certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification Agreement. This
certificate.validation@intertek.com or by scanning the code to the right with a smartphone. The certificate remains the property of Intertek, to whom it must be returned upon
request. Validity of this certificate may be verified at http://www.intertek.com/business-assurance/certificate-validation/