Identity
- Trade Name
- ALBAsera® Anti-Wra EUDAMED
- Device Name
- ALBAsera® Anti-Wra EUDAMED
- Model / Reference
- Z231 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242470301 EUDAMED
- Basic UDI-DI
- B-05060242470301 EUDAMED
- EMDN Code
- W0103030501 OTHER ANTIGEN TYPING REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ALBAsera® Anti-Wra by Alba Bioscience Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060242470301 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alba Bioscience Limited
- EUDAMED SRN
- GB-MF-000029300
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 174dc3e0-550c-4182-972c-a61e91597a37 61 fields · synced May 22, 2026