Identity
- Trade Name
- ORTHO™ Anti-Lea EUDAMED
- Device Name
- ORTHO™ Sera Anti - Lea EUDAMED
- Model / Reference
- 6904497 (FD212B) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10758750013234 EUDAMED
- Basic UDI-DI
- B-10758750013234 EUDAMED
- EMDN Code
- W0103030501 OTHER ANTIGEN TYPING REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Northern Ireland 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
ORTHO™ Anti-Lea 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-10758750013234 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Alba Bioscience Limited
- EUDAMED SRN
- GB-MF-000029300
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 89366200-78e5-46c7-9c25-8c42d42da82b 61 fields · synced Aug 3, 2026