Navigation path


Notification

Found : 17
  Body (History):

BERLIN CERT PRÜF- UND ZERTIFIZIERSTELLE FÜR MEDIZINPRODUKTE GMBH AN DER TECHNISCHEN UNIVERSITÄT BERLIN
Dovestraße 6
10587 BERLIN
Country : Germany

Phone : +49:30:314 25111
Fax : +49:30:314 23719

Email : info@berlincert.de
Website : http://www.berlincert.de

Notified Body number : 0633

Version(s): 1 2 3 4 5 6 7

Last update : 25/05/2009
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 25/05/2009                 Version(s): 1 2 3 4 5

Products Procedures Articles/Annexes Limitations
Active medical devices, except
 
   - devices for hyperbaric therapy
EC type-examination
EC verification
Annex III
Annex IV
 
   - devices for imaging and radiotherapy utilizing ionizing radiation
EC type-examination
EC verification
Annex III
Annex IV
 
   - devices for laser surgery
EC type-examination
EC verification
Annex III
Annex IV
 
   - devices for laser therapy
EC type-examination
EC verification
Annex III
Annex IV
 
   - devices for magnetic resonance imaging
EC type-examination
EC verification
Annex III
Annex IV
 
   - equipment and devices for hyperbaric therapy
EC type-examination
EC verification
Annex III
Annex IV
 
   - litholripter
EC type-examination
EC verification
Annex III
Annex IV
 
   - software
EC type-examination
EC verification
Annex III
Annex IV
 
   - ultrasonic equipment
EC type-examination
EC verification
Annex III
Annex IV
 
Anaesthetic and respiratory equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Devices for anaesthesia and ventilation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
devices for disinfection and sterilisation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
devices for stimulation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
rehabilitation devices and active protheses
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
respiratory devices, devices for for oxygen therapy and inhalation anaesthesia
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
surgical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Set page to normal font size Increase font size by 200 percentprint this page