Identity
- Trade Name
- sthemO Fib M EUDAMED
- Device Name
- sthemO Fib EUDAMED
- Model / Reference
- sthemO Fib EUDAMED01224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 13607450012245 EUDAMED
- Basic UDI-DI
- 36074509FIB000354 EUDAMED
- Unit of Use DI
- 03607450012248 EUDAMED
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
sthemO Fib M by Diagnostica Stago — Class B — 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 | 36074509FIB000354 | Class B | Active |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (1)
- EUDAMED 0750dd94-870e-446e-b7a8-89cf7cc9b190 61 fields · synced Jun 18, 2026