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Notification

Found : 26
  Body :

APRAGAZ A.S.B.L.
Chaussée de Vilvorde, 156
1120 BRUXELLES
Country : Belgium

Phone : +32/2 264 03 60
Fax : +32/2 268 89 58

Email : info@apragaz.com
Website : www.apragaz.com

Notified Body number : 0029

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Last update : 26/10/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 25/08/2011                 Version(s): 1 2 3 4

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 0104 - Non-active medical devices with measuring function
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 0106 - Non-active instruments
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 0302 - Suture material and clamps
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 0303 - Other medical devices for wound care
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 0402 - Dental materials
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 0403 - Dental implants
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 1104 - Active surgical devices
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 1106 - Active dental devices
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 1107 - Active devices for disinfection and sterilisation
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 1109 - Active devices for patient positioning and transport
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 1111 - Software
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
   - *MD 1302 - Monitoring devices of vital physiological parameters
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1402 - Devices utilising non-ionizing radiation
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex II
Annex V
Class I, IIa and IIb only 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery Class I, IIa and IIb only
*MDS 7006 - Medical devices in sterile condition Class I, IIa and IIb only
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