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  Body :

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 : zert@berlincert.de
Website : http://www.berlincert.de

Notified Body number : 0633

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

Last update : 22/04/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 22/04/2010                 Version(s): 1 2 3 4 5 6 7

Products Procedures Articles/Annexes Limitations
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
EC type-examination
EC verification
Annex III
Annex IV
 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Except hyperbaric chambers 
   - *MD 1103 - Devices for stimulation or inhibition
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - *MD 1104 - Active surgical devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - *MD 1105 - Active ophthalmologic devices
EC type-examination
EC verification
Annex III
Annex IV
 
   - *MD 1106 - Active dental devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - *MD 1107 - Active devices for disinfection and sterilisation
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - *MD 1108 - Active rehabilitation devices and active prostheses
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - *MD 1109 - Active devices for patient positioning and transport
EC type-examination
EC verification
Annex III
Annex IV
 
   - *MD 1111 - Software
EC type-examination
EC verification
Annex III
Annex IV
 
*MD 1200 - Devices for imaging
 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Except magnetic resonance imaging 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - *MD 1302 - Monitoring devices of vital physiological parameters
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
Annex III
Annex IV
 
   - *MD 1403 - Devices for hyperthermia / hypothermia
EC type-examination
EC verification
Annex III
Annex IV
 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition  
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