Identity
- Trade Name
- Biofix EUDAMED
- Device Name
- Biofix Knee Spacer with gentamicin EUDAMED
- Model / Reference
- 881171 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700448208132 EUDAMED
- Basic UDI-DI
- B-03700448208132 EUDAMED
- EMDN Code
- P090908 KNEE PROSTHESES SPACERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Biofix by Synergie Ingenierie Medicale — Class III — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03700448208132 | Class III | Active |
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Manufacturer
- Manufacturer
- Synergie Ingenierie Medicale
- EUDAMED SRN
- FR-MF-000001635
Sources (1)
- EUDAMED 2b57a47b-94e2-4cc1-8cd8-ed411d660792 61 fields · synced Oct 6, 2026