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BIPOLAR SHELL WITH INSERT (CoCr) Ø38mm
EUDAMEDClass III (EU MDR)
Ref 02.8438Model BIPOLAR SHELL WITH INSERT (CoCr) Ø38mm
Identity
- Trade Name
- BIPOLAR SHELL WITH INSERT (CoCr) Ø38mm EUDAMED
- Device Name
- BIPOLAR SHELL WITH INSERT (CoCr) Ø38mm EUDAMED
- Model / Reference
- BIPOLAR SHELL WITH INSERT (CoCr) Ø38mm EUDAMED02.8438 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659056103 EUDAMED
- Basic UDI-DI
- B-05051659056103 EUDAMED
- EMDN Code
- P090804050102 METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Metallic femoral head prosthesis
BIPOLAR SHELL WITH INSERT (CoCr) Ø38mm by Covision Medical Technologies Ltd. — 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-05051659056103 | Class III | Active |
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Manufacturer
- Manufacturer
- Covision Medical Technologies Ltd.
- EUDAMED SRN
- GB-MF-000025081
- Authorised Representative
- Covision Medical Technologies (Ireland) Limited IE-AR-000031129
Sources (1)
- EUDAMED 2cf01edf-402a-4894-8f5b-7bbdfb03e92c 61 fields · synced Jul 10, 2026