IVDR: 5th Notified Body on NANDO!

The NANDO database is richer for a new Notified Body under the IVDR!

TÜV Rheinland LGA Products GmbH is the 5th Notified Body (4th within the EU-27) notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.

TÜV Rheinland LGA Products GmbH
Tillystraße 2
90431 Nürnberg
Country : Germany

Phone : +49 (0) 9116555225
Fax : +49 (0) 9116555226

Email : service@de.tuv.com
Website : www.tuv.com/safety

Notified Body number : 0197

Here below, a short extract what the Notification covers:

  • IVR 0403 Other devices intended to be used for human genetic testing
  • IVR 0702 Devices which are controls without a qualitative assigned value
  • IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis
  • IVR 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents
  • IVR 0502 Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration

You can find the full scope of its designation on the following link.

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