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Femoral Head CoCr
EUDAMEDClass III (EU MDR)
Ref BO76.1692.000.00Model Femoral Head CoCrMo D.28 L
Identity
- Device Name
- Femoral Head CoCr EUDAMED
- Model / Reference
- Femoral Head CoCrMo D.28 L EUDAMEDBO76.1692.000.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050507910045 EUDAMED
- Basic UDI-DI
- B-08050507910045 EUDAMED
- Direct Marketing DI
- 08050507910045 EUDAMED
- EMDN Code
- P090804050202 METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT 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
Category: Metallic femoral head prosthesis
Femoral Head CoCr by Lincotek Bologna S.r.l — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
- Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
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-08050507910045 | Class III | Active |
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Manufacturer
- Manufacturer
- Lincotek Bologna S.r.l
- EUDAMED SRN
- IT-MF-000033944
Sources (1)
- EUDAMED b5124241-1539-408d-926a-fb971ac7e42a 61 fields · synced Jun 19, 2026