The NANDO database has a new Notified Body under the MDR!
AFNOR Certification is the 46th EU Notified Body notified under Regulation (EU) 2017/745 on medical devices – MDR.
AFNOR Certification
11 rue Francis de Pressensé 93571
93571 La Plaine Saint-Denis Cedex
France
Phone: +33 (0)1 41 62 60 98
Email: marquage-ce@afnor.org
Website: www.afnor.org
Body Number: 0333
The extract from the Notification:
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- MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
- XI(A) is limited to class Im, Ir, Is & IIa devices
- MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
- XI(A) is limited to class Im, Ir, Is & IIa devices
- MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
- MDA 0305 Active non-implantable devices for stimulation or inhibition
- XI(A) is limited to class Im, Ir, Is & IIa devices
- MDA 0307 Active non-implantable respiratory devices
- Limited to hyperbaric chambers
- MDA 0312 Other active non-implantable surgical devices
- XI(A) is limited to class Im, Ir, Is & IIa devices
- MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
- XI(A) is limited to class Im, Ir, Is & IIa devices
- MDA 0315 Software
- XI(A) is limited to class Im, Ir, Is & IIa devices
- MDA 0316 Medical gas supply systems and parts thereof
- MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
- XI(A) is limited to class Im, Ir, Is & IIa devices
- …
- MDS 1005 Devices in sterile condition
- Limited to the following sterilisation processes:ethylene oxide gas (EOG), moist heat, radiation (gamma, x-ray, electron beam)
- MDS 1006 Reusable surgical instruments
- …
- MDT 2013 Devices which have undergone reprocessing
- MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
The full designation scope is available here.
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