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Femoral Head Adapter
EUDAMEDClass III (EU MDR)
Ref BO76.3121.000.00Model Femoral Head Ceramic Biolox®Delta Revision 16/18 Adapter S -3Ref BO76.3122.000.00Model Femoral Head Ceramic Biolox®Delta Revision 16/18 Adapter M +0
Identity
- Device Name
- Femoral Head Adapter EUDAMED
- Model / Reference
- Femoral Head Ceramic Biolox®Delta Revision 16/18 Adapter S -3 EUDAMEDBO76.3121.000.00 EUDAMEDFemoral Head Ceramic Biolox®Delta Revision 16/18 Adapter M +0 EUDAMEDBO76.3122.000.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050391091912 EUDAMED08050391091929 EUDAMED
- Basic UDI-DI
- B-08050391091912 EUDAMEDB-08050391091929 EUDAMED
- Direct Marketing DI
- 08050391091912 EUDAMED08050391091929 EUDAMED
- EMDN Code
- P090804050299 FEMORAL HEADS FOR PRIMARY IMPLANT OF TOTAL PROSTHESES - OTHER 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 Adapter by Lincotek Bologna S.r.l — Class III — MDD — 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-08050391091912 | Class III | Active |
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Manufacturer
- Manufacturer
- Lincotek Bologna S.r.l
- EUDAMED SRN
- IT-MF-000033944
Sources (2)
- EUDAMED 153fda82-b4b2-4b5c-94c9-67f1133b5002 61 fields · synced Oct 6, 2026
- EUDAMED f3e298d5-ec50-40d4-8eeb-5335be2597d2 61 fields · synced May 19, 2026