Name and address of the notified
bodie
|
Responsible for the following
products
|
Responsable for the following
procedures/modules
|
Annexes/articles of the
directives
|
DEKRA CERTIFICATION SERVICES
(DCS)
GmbH
Benannt für Handwerkstrasse
1570565 Stuttgart
GERMANY
T : 00 49 711 7861 2778
F : 00 49 711 7861 2615
URL :
Email :
|
Non-active medical devices:
- orthopaedic implants
- soft-tissue implants
- function implants
- disposable medical
devices
- 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
|
Full quality assurance
Type-examination
EC verification
Production quality assurance
Product quality assurance
|
Annex II
Annex III
Annex IV
Annex V
Annex VI
|
|
|
Production quality assurance
Product quality assurance
Full quality assurance
Type-examination
EC verification
|
Annex V
Annex VI
Annex II
Annex III
Annex IV
|
|
Active medical devices :
- devices to ascertain vital
functions
- equipment for extracorporeal
circuits, infusions and haemophoresis
- anaesthesia devices, incubators,
respirators and oxygen therapy equipment
- surgical equipment and ancillary
surgical equipment
- imaging equipment :
- with ionizing
radiation
- with non-ionizing
radiation
- stimulation devices
- radiotherapy devices :
- with ionizing
radiation
- with non-ionizing
radiation
- ophtalmological devices
- dental equipment
- protheses and rehabilitation
devices
- disinfection and sterilization
equipment
|
Full quality assurance
Type-examination
EC verification
Production quality assurance
Product quality assurance
|
Annex II
Annex III
Annex IV
Annex V
Annex VI
|
Name and address of the notified
bodie
|
Responsible for the following
products
|
Responsable for the following
procedures/modules
|
Annexes/articles of the
directives
|
DEKRA CERTIFICATION SERVICES
(DCS)
GmbH
Benannt für Handwerkstrasse
1570565 Stuttgart
GERMANY
T : 00 49 711 7861 2778
F : 00 49 711 7861 2615
URL :
Email :
|
All active implantable medical
devices
|
Full quality assurance
Type-examination
EC verification
Production quality assurance
|
Annex II
Annex III
Annex IV
Annex V
|