Below is a list of useful links…
US Food and Drug Administration (FDA)
California Food and Drug Branch (FDB)
European commission
Notified Bodies (Designated Under Medical Devices Regulation )
NB # | Name | Country |
NB 2265 | 3EC International a.s. | Slovakia |
NB 2797 | BSI Group The Netherlands B.V. | Netherlands |
NB 2409 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Hungary |
NB 1912 | DARE!! Services B.V. | Netherlands |
NB 0344 | DEKRA Certification B.V. | Netherlands |
NB 0124 | DEKRA Certification GmbH | Germany |
NB 2460 | DNV GL Presafe AS | Norway |
NB 0297 | DQS Medizinprodukte GmbH | Germany |
NB 0459 | GMED | France |
NB 0051 | IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. | Italy |
NB 0373 | ISTITUTO SUPERIORE DI SANITA’ | Italy |
NB 2862 | Intertek Medical Notified Body AB | Sweden |
NB 0483 | MDC MEDICAL DEVICE CERTIFICATION GMBH | Germany |
NB 0482 | MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH | Germany |
NB 0050 | National Standards Authority of Ireland (NSAI) | Ireland |
NB 0598
(ex-0403) |
SGS FIMKO OY | Finland |
NB 0197 | TÜV Rheinland LGA Products GmbH | Germany |
NB 0123 | TÜV SÜD Product Service GmbH Zertifizierstellen | Germany |
NB 2696 | UDEM Adriatic d.o.o. | Croatia |
Where to Purchase Standards
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