Resources

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

 

News and Information