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BIOSCOT® Anti-Leb Monoclonal Human IgA Blood Grouping Reagent (Cell Line: P3F23…
EUDAMEDClass C (EU MDR)
Ref NY-2ML-B
Identity
- Device Name
- BIOSCOT® Anti-Leb Monoclonal Human IgA Blood Grouping Reagent (Cell Line: P3F234MD4) EUDAMED
- Model / Reference
- NY-2ML-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053252420948 EUDAMED
- Basic UDI-DI
- 4053252NYBTRV2 EUDAMED
- EMDN Code
- W01030399 IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
BIOSCOT® Anti-Leb Monoclonal Human IgA Blood Grouping Reagent (Cell Line: P3F23… by Millipore (UK) Ltd. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4053252NYBTRV2 | Class C | Active |
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Manufacturer
- Manufacturer
- Millipore (UK) Ltd.
- EUDAMED SRN
- GB-MF-000025157
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED ec5649fa-6800-4e24-9f2d-71218f5effe0 61 fields · synced Jul 12, 2026