Identity
- Device Name
- FIBRINOGEN EUDAMED
- Model / Reference
- 31600 EUDAMED23804 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287100181 EUDAMED08435287108279 EUDAMED
- Basic UDI-DI
- B-08435287100181 EUDAMEDB-08435287108279 EUDAMED
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) EUDAMED
Classification
- Device Class
- Class IVD General 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
Fibrinogen by Biosystems S.a. — 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-08435287100181 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 8b8767e3-3dc1-4305-a1d0-12824ecc786c 61 fields · synced Jul 11, 2026
- EUDAMED 7d5d6fc4-add0-4fd4-bad5-aee06a871555 61 fields · synced May 18, 2026