Identity
- Trade Name
- ThromboGUARD FII FV EUDAMED
- Device Name
- ThromboGUARD FII FV EUDAMED
- Model / Reference
- AB0023 EUDAMEDAB0040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760322820102 EUDAMED03760322820157 EUDAMED
- Basic UDI-DI
- 376032282CGENF2F5FW EUDAMED
- EMDN Code
- W0106010115 COMBINED FACTOR II / FACTOR V LEIDEN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ThromboGUARD FII FV by Appolon Bioteck — Class C — 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 | 376032282CGENF2F5FW | Class C | Active |
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Manufacturer
- Manufacturer
- Appolon Bioteck
- EUDAMED SRN
- FR-MF-000022234
Sources (2)
- EUDAMED a1df1fd1-9b17-422a-a9c1-4fb420426304 61 fields · synced Jul 25, 2026
- EUDAMED 8c95f451-e0ed-4719-9687-003704534964 61 fields · synced Jul 25, 2026