The NANDO database has a new Notified Body under the MDR!
TÜV SÜD Danmark is the 45th EU Notified Body notified under Regulation (EU) 2017/745 on medical devices – MDR.
TÜV SÜD Danmark
Strandvejen 125
2900 Hellerup
Denmark
Phone: +45 4477 0010
Email: info.dk@tuvsud.com
Website: https://www.tuvsud.com/en-gb/country/denmark
Body Number: 2443
The extract from the Notification:
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- MDA 0101 Active implantable devices for stimulation/inhibition/monitoring
- Annex IX(I), Annex IX(II)
- MDA 0102 Active implantable devices delivering drugs or other substances
- Annex IX(I), Annex IX(II)
- MDA 0103 Active implantable devices supporting or replacing organ functions
- Annex IX(I), Annex IX(II)
- MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
- Annex IX(I), Annex IX(II)
- MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
- Annex IX(I), Annex IX(II)
- Limited to ultrasound technology
- MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
- Annex IX(I), Annex IX(II)
- MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
- Annex IX(I), Annex IX(II)
- MDA 0305 Active non-implantable devices for stimulation or inhibition
- Annex IX(I), Annex IX(II)
- MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
- Annex IX(I), Annex IX(II)
- Limited to infusion systems
- MDA 0307 Active non-implantable respiratory devices
- Annex IX(I), Annex IX(II)
- MDA 0310 Active non-implantable devices for ear, nose and throat
- Annex IX(I), Annex IX(II)
- Limited to hearing aids
- MDA 0312 Other active non-implantable surgical devices
- Annex IX(I), Annex IX(II)
- Excluding surgical robotic
- MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
- Annex IX(I), Annex IX(II)
- Excluding active limb prosthesis
- MDA 0315 Software
- Annex IX(I), Annex IX(II)
- MDA 0318 Other active non-implantable devices
- Annex IX(I), Annex IX(II)
- MDA 0101 Active implantable devices for stimulation/inhibition/monitoring
The full designation scope is available here.
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