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BIPOLAR SHELL WITH INSERT (SS) Ø44mm
EUDAMEDClass III (EU MDR)
Ref 02.8144Model BIPOLAR SHELL WITH INSERT (SS) Ø44mm
Identity
- Trade Name
- BIPOLAR SHELL WITH INSERT (SS) Ø44mm EUDAMED
- Device Name
- BIPOLAR SHELL WITH INSERT (SS) Ø44mm EUDAMED
- Model / Reference
- BIPOLAR SHELL WITH INSERT (SS) Ø44mm EUDAMED02.8144 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659056028 EUDAMED
- Basic UDI-DI
- B-05051659056028 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
BIPOLAR SHELL WITH INSERT (SS) Ø44mm by Covision Medical Technologies Ltd. — 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-05051659056028 | 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 94ac9722-5655-4c3b-8411-c9936238551f 61 fields · synced Oct 6, 2026