Identity
- Trade Name
- Fibrinogen‐ONE EUDAMEDFibrinogen‐ONE Calibrator EUDAMED
- Device Name
- Fibrinogen‐ONE EUDAMEDFibrinogen‐ONE Calibrator EUDAMED
- Model / Reference
- I0217 EUDAMEDIS02295 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-I0217NH EUDAMEDD-IS02295N6 EUDAMED
- Basic UDI-DI
- B-I0217NH EUDAMEDB-IS02295N6 EUDAMED
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) EUDAMEDW0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
Fibrinogen‐ONE 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-I0217NH | 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 6b341f1e-7919-4602-9539-480d4df4a3f0 61 fields · synced Jun 20, 2026
- EUDAMED fca232a2-70e2-405c-bd54-433472783b95 61 fields · synced May 17, 2026