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ORTHO™ Sera Reagent Control
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 6986728 (FD272B)
Identity
- Trade Name
- ORTHO™ Sera Reagent Control EUDAMED
- Device Name
- ORTHO™ Sera Reagent Control EUDAMED
- Model / Reference
- 6986728 (FD272B) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10758750031566 EUDAMED
- Basic UDI-DI
- B-10758750031566 EUDAMED
- EMDN Code
- W0103030499 IMMUNOHAEMATOLOGY CONTROLS - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List A 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™ Sera Reagent Control by Alba Bioscience Limited — Class IVD Annex II List A — 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-10758750031566 | Class IVD Annex II List A | 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 589ef5e8-429b-44dc-927f-0439356db4ed 61 fields · synced Sep 17, 2026