Identity
- Trade Name
- HemosIL FDP Controls EUDAMED
- Device Name
- HemosIL FDP EUDAMED
- Model / Reference
- 0020009920 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426950581918 EUDAMED
- Basic UDI-DI
- 8426950581895A7 EUDAMED
- EMDN Code
- W0103020502 FIBRINOGEN DEGRADATION PRODUCTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
HemosIL FDP Controls by Biokit, S.a. — 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 | 8426950581895A7 | Class C | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED 2a498299-9808-45bb-9b00-9ffb16521498 61 fields · synced Jul 29, 2026