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β‐2 Microglobulin 4 levels Standard
EUDAMEDClass IVD General (EU MDR)
Ref IS02297Ref I0214
Identity
- Trade Name
- β‐2 Microglobulin 4 levels Standard EUDAMEDβ‐2 Microglobulin EUDAMED
- Device Name
- β‐2 Microglobulin 4 levels Standard EUDAMEDβ‐2 Microglobulin EUDAMED
- Model / Reference
- IS02297 EUDAMEDI0214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IS02297NA EUDAMEDD-I0214NB EUDAMED
- Basic UDI-DI
- B-IS02297NA EUDAMEDB-I0214NB EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMEDW0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
β‐2 Microglobulin 4 levels Standard by C.p.m. Compagnia Per La Medicina S.r.l. — 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-IS02297NA | Class IVD General | Active |
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Manufacturer
- Manufacturer
- C.p.m. Compagnia Per La Medicina S.r.l.
- EUDAMED SRN
- IT-MF-000010738
Sources (2)
- EUDAMED 6a85534f-eec0-4cfb-8e63-0bf7eef6bacc 61 fields · synced Oct 7, 2026
- EUDAMED 39d9f2c5-0670-42a0-96da-d1a6295a9702 61 fields · synced May 19, 2026