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Femoral Head Ceramic R
EUDAMEDClass III (EU MDR)
Ref BO76.3120.000.00Model Femoral Head Ceramic Biolox®Delta Revision 16/18 D.40
Identity
- Device Name
- Femoral Head Ceramic R EUDAMED
- Model / Reference
- Femoral Head Ceramic Biolox®Delta Revision 16/18 D.40 EUDAMEDBO76.3120.000.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050391091905 EUDAMED
- Basic UDI-DI
- B-08050391091905 EUDAMED
- Direct Marketing DI
- 08050391091905 EUDAMED
- EMDN Code
- P0908040504 REVISION FEMORAL HEADS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Femoral Head Ceramic R by Lincotek Bologna S.r.l — 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-08050391091905 | Class III | Active |
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Manufacturer
- Manufacturer
- Lincotek Bologna S.r.l
- EUDAMED SRN
- IT-MF-000033944
Sources (1)
- EUDAMED c6338f20-cd83-446b-b24d-4d3333176d94 61 fields · synced Oct 6, 2026