← Back to catalogue
BIOPHEN™ FVIII variant
EUDAMEDClass C (EU MDR)
Ref 227102Model Factor VIII (FVIII) bovine
Identity
- Trade Name
- BIOPHEN™ FVIII variant EUDAMED
- Model / Reference
- Factor VIII (FVIII) bovine EUDAMED227102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03663537084676 EUDAMED
- Basic UDI-DI
- 366353700097BW EUDAMED
- EMDN Code
- W0103020207 COAGULATION FACTOR VIII EUDAMED
Classification
- Device Class
- Class C 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
Yes
EUDAMED
BIOPHEN™ FVIII variant by Hyphen Biomed — 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 | 366353700097BW | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HYPHEN BioMed
- EUDAMED SRN
- FR-MF-000002214
Sources (1)
- EUDAMED 000f8472-dfc9-4c18-b0d8-47b3f15c033a 61 fields · synced Jul 9, 2026