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ß2-microglobulin
EUDAMEDClass IVD General (EU MDR)
Ref 3000-2307Ref 3000-2192
by Biokit S.A.
Identity
- Trade Name
- ß2-microglobulin EUDAMEDß2-microglobulin Calibrator EUDAMED
- Device Name
- ß2-microglobulin EUDAMEDß2-microglobulin Calibrator EUDAMED
- Model / Reference
- 3000-2307 EUDAMED3000-2192 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-3000-2307D8 EUDAMEDD-3000-2192DF EUDAMED
- Basic UDI-DI
- B-3000-2307D8 EUDAMEDB-3000-2192DF EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ß2-microglobulin by Biokit, S.a. — 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-3000-2307D8 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (2)
- EUDAMED bad10f5b-60c5-4d5c-a9c1-a3e79b82821a 61 fields · synced Jul 28, 2026
- EUDAMED 4da7c70b-53b9-47f5-9f66-406bc6d6704a 61 fields · synced May 19, 2026