APRAGAZ A.S.B.L.

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
Notified Body number : 0029
Website : APRAGAZ A.S.B.L.

Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
MD 0102: Non-active devices for injection, infusion, transfusion and dialysis
MD 0104: Non-active Devices with measuring function
MD 0106: Non-active instruments
MD 0301: Bandages and wound dressings
MD 0302: Suture material and clamps
MD 0303: Other material for wound care
MD 0401: Non-active dental equipment and instruments
MD 0402: Dental Materials
MD 0403: Dental Implants
MD 1101: Devices for exracorporeal circulation, infusion and hemopheresis
MD 1102: Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anesthesia
MD 1104: Active surgical devices
MD 1106: Active dental devices
MD 1107: Active devices for disinfection and sterilisation
MD 1109: Active devices for patient positioning and transport
MD 1111: Software
MD 1301: Monitoring devices of non-vital physiological parameters
MD 1302: Monitoring devices of vital physiological parameters
MD 1402: Devices utilising non-ionizing radiation

Horizontal Technical Competence
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition

ANNEXES
ANNEX II: Full Quality Assurance
ANNEX IV: EC Verification
ANNEX V: Production Quality Assurance