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BIPOLAR SHELL (SS) WITH INSERT (XL) Ø40mm
EUDAMEDClass III (EU MDR)
Ref 02.9840Model BIPOLAR SHELL (SS) WITH INSERT (XL) Ø40mmRef 02.8146Model BIPOLAR SHELL WITH INSERT (SS) Ø46mm
Identity
- Trade Name
- BIPOLAR SHELL (SS) WITH INSERT (XL) Ø40mm EUDAMEDBIPOLAR SHELL WITH INSERT (SS) Ø46mm EUDAMED
- Device Name
- BIPOLAR SHELL (SS) WITH INSERT (XL) Ø40mm EUDAMEDBIPOLAR SHELL WITH INSERT (SS) Ø46mm EUDAMED
- Model / Reference
- BIPOLAR SHELL (SS) WITH INSERT (XL) Ø40mm EUDAMED02.9840 EUDAMEDBIPOLAR SHELL WITH INSERT (SS) Ø46mm EUDAMED02.8146 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659063415 EUDAMED05051659056035 EUDAMED
- Basic UDI-DI
- B-05051659063415 EUDAMEDB-05051659056035 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 (SS) WITH INSERT (XL) Ø40mm by Covision Medical Technologies Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Metallic femoral head prosthesis.
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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-05051659063415 | 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 (2)
- EUDAMED f20f0ed5-b0ff-4d93-b96b-a3ab7c785a4f 61 fields · synced Oct 6, 2026
- EUDAMED bf2e1976-7ece-4fcc-ae9f-32dc0fb32918 61 fields · synced May 19, 2026