TITLE>HosmaT : 0482
0482 - NOTIFIED BODY (UNDER DIRECTIVE 93/42/EEC Medical devices)

Name and address of the notified bodie
Responsible for the following products
Responsable for the following procedures/modules
Annexes/articles of the directives

MEDCERT
ZERTIFIZIERUNGS UND
PRÜFUNGSGESELLSHAFT FÜR DIE MEDIZIN GmbH
Vorsetzen 32
D - 20459 Hamburg

T : 00 49 40 369 51 7982
F : 00 49 40 369 51 7983
URL :
www.medcert.de
Email :
medcert@germanlloyd.org

Non-active medical devices:

  • orthopaedic implants
  • soft-tissue implants
  • function implants
  • disposable medical products
  • anaesthetic, orthopaedic and rehabilitation products
  • non-energy medical instrumentation
  • reusable non-active medical instruments
  • bandages and dressings
  • suture material and clamps
  • dental equipment and instruments
  • dental materials
  • dental implants

 Active medical devices :

  • vital-parameter monitoring and plotting devices
  • equipment for extracorporeal circuits, infusions and haemophoresis
  • breathing apparatus and oxygen-therapy equipment including hyperbaric therapy chambers
  • inhalation anaesthesizing equipment
  • surgical equipment and accessories, including lithotriptors ; Hf, Laser and ultra-sound surgery ; endoscopes
  • X-ray equipment apart form CT and angiography
  • imaging equipment using non-ionizing radiation, with the exception of MR
  • stimulation devices
  • radiotherapy equipment with non-ionizing radiation
  • ophtalmological devices
  • dental equipment
  • disinfection and sterilization equipment
  • protheses and rehabilitation devices
  • patient storage and transport equipment
  • medical supply units

Full quality assurance
Type-examination
EC verification
Production quality assurance
Product quality assurance

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Annex II
Annex III
Annex IV
Annex V
Annex VI

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


site - http://www.hosmat.com - retour / back - dernière mise à jour / last update : 10 janvier 2000