Identity
- Trade Name
- sthemO II EUDAMED
- Device Name
- sthemO II EUDAMED
- Model / Reference
- 01229 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 13607450012290 EUDAMED
- Basic UDI-DI
- 3607450FACT0017DN EUDAMED
- Unit of Use DI
- 03607450012293 EUDAMED
- EMDN Code
- W0103020202 COAGULATION FACTOR II ( PROTHROMBIN ) 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
Yes
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 II 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 | 3607450FACT0017DN | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (1)
- EUDAMED 262235f0-e11b-41f6-a898-e8f385ff1c7d 61 fields · synced Jun 19, 2026