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Alinity c β2-Microglobulin Standard
EUDAMEDClass C (EU MDR)
Ref 01R0901
by Biokit S.A.
Identity
- Trade Name
- Alinity c β2-Microglobulin Standard EUDAMED
- Device Name
- Alinity c β2-Microglobulin Reagent Kit EUDAMED
- Model / Reference
- 01R0901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00380740151027 EUDAMED
- Basic UDI-DI
- 8436003070153X2 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain 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
Alinity c β2-Microglobulin Standard by Biokit, S.a. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 8436003070153X2 | Class C | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED fa2154ff-a672-4aee-b97c-d04d4290e219 61 fields · synced Jun 18, 2026