VENTANA PD-L1 (SP263) Assay
by Roche Diagnostics GmbH Germany EUDAMED
Ref 07419821001 EMDN W01030709
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number7613336020019M | Date10 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- V75 010283 0684 Supplemented
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 28 May 2026
- Expires
- 27 Mar 2029
- Reason
- Change approved
Specification
- Model / Reference
- 07419821001
- Primary DI / UDI-DI
- 04015630976478
- Basic UDI-DI
- 7613336020019M
- EMDN Code
- W01030709 Primary antisera for immunohistology
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006260
Other devices from Roche Diagnostics GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED c8d93349-e0b8-4677-a06a-9184343d5905