Identity
- Trade Name
- ALBAclone® Anti-P1 EUDAMED
- Device Name
- ALBAclone® Anti-P1 EUDAMED
- Model / Reference
- Z202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242470257 EUDAMED
- Basic UDI-DI
- B-05060242470257 EUDAMED
- EMDN Code
- W0103030501 OTHER ANTIGEN TYPING REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
ALBAclone® Anti-P1 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-05060242470257 | 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 361b2d18-beb6-4b72-b9b7-6f268161ef8b 61 fields · synced Jul 17, 2026