The NANDO database newly lists 19 Notified Bodies under the MDR!
ISTITUTO SUPERIORE DI SANITA has been notified under the Regulation (EU) 2017/745 on medical devices – MDR.
ISTITUTO SUPERIORE DI SANITA
Viale Regina Elena,299
00161 -Roma
Country : Italy
Phone : +39 06 49906146
Fax : +39 06 4990315
Email : roberta.marcoaldi@iss.it
Website : www.iss.it
Notified Body number : 0373
You can find the full scope of its notification on the following link. Here below, an extract from NANDO:
- 3. Active non-implantable therapeutic devices and general active non-implantable devices
- MDA 0301 Active non-implantable devices utilising ionizing radiation
- Limited to therapeutic cyclotrons and linear accelerators
- 1. Non-active implants and long term surgically invasive devices
- 2. Non-active non-implantable devices
- MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
- MDS 1005 Devices in sterile condition
- Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam, moist heat sterilisation, radiation sterilisation (gamma-ray, electron beam), dry heat.
- MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
- MDS 1001 Devices incorporating medicinal substances
- MDS 1011 Devices in systems or procedure packs
- MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
- …
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