Roche Diagnostics, S.L.U.
Active in EUDAMEDSpainfrom SRN EUDAMED SRN ES-MF-000000700
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
TAONET Pro-Mobile interface Ref 08148325001
Regimes: CE IVDR Registry: EUDAMEDTAONET Pro Ref 09230823001
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- ES-MF-000000700
- EU VAT number
- B61503355
- EUDAMED status
- Active
- EUDAMED registered name
- Roche Diagnostics, S.L.U.
- Registered address
- 171-173, Av. de la Generalitat, E-08174, Sant Cugat del Vallès, Spain
- [email protected]
- Phone
- +34 93 583 40 00
- PRRC contact
- Gemma Banks Barrachina
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 2next expiry 31 Aug 2028
TÜV Rheinland LGA Products GmbH 0197 2 certificates
- HX 1767578-1 Active
Quality management system EU IVDR
- Issued
- 1 Sep 2023
- Expires
- 31 Aug 2028
- IX 1767578-1 Active
Technical documentation EU IVDR
- Issued
- 7 Apr 2025
- Expires
- 31 Aug 2028
- Reason
- Other
Frequently asked questions
How many devices does Roche Diagnostics, S.L.U. have in the registry?
The registry currently lists 2 devices for Roche Diagnostics, S.L.U.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roche Diagnostics, S.L.U.'s devices?
Among its 2 most recently registered devices, Roche Diagnostics, S.L.U. has devices listed in EUDAMED (2 devices).
What risk classes do Roche Diagnostics, S.L.U.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Roche Diagnostics, S.L.U.'s devices are IVDR Class C. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Roche Diagnostics, S.L.U.?
EUDAMED lists 2 certificates for Roche Diagnostics, S.L.U. (quality management system; technical documentation) under IVDR. 1 is recorded with the status issued. The most recent was issued on 7 Apr 2025.
What are the newest devices from Roche Diagnostics, S.L.U. in the registry?
The most recently registered devices listed for Roche Diagnostics, S.L.U. include TAONET Pro-Mobile interface and TAONET Pro.