Search the Device Catalogue
Search all 165 devices listed in our Notified Body confirmation letter (TÜV Rheinland, NB 0197, 2026-07-10) under Regulation (EU) 2024/1860 — by pathogen, series, test method or IVDR risk class. Device names are reproduced verbatim from the confirmation letter.
EU regulatory status
165 devices listed in the Notified Body confirmation letter (TÜV Rheinland, NB 0197) under Regulation (EU) 2024/1860 — transition to 2028-12-31 (Class C) / 2029-12-31 (Class B), subject to the conditions of that Regulation. The confirmation letter is not an IVDR certificate, a CE certificate or an EU Declaration of Conformity.
Find a device
Loading the catalogue…
| # | Device name | Market series | Basic UDI-DI | IVDR class |
|---|
Intended use, performance and documentation
Intended use, sample types, performance characteristics and specifications are as stated in the Instructions for Use (IFU) and the applicable conformity documentation for each device. Device availability and registration status are subject to the requirements of each market.
Need a quotation, a specific IFU, or the current documentation status? Write to xx_hz@hotmail.com or use the inquiry form.