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HIPEX Ti PLASMA ACETABULAR SHELL CEMENTLESS SIZE 58
EUDAMEDClass III (EU MDR)
Ref 09.2158Model HIPEX Ti PLASMA ACETABULAR SHELL CEMENTLESS SIZE 58
Identity
- Trade Name
- HIPEX Ti PLASMA ACETABULAR SHELL CEMENTLESS SIZE 58 EUDAMED
- Device Name
- HIPEX Ti PLASMA ACETABULAR SHELL CEMENTLESS SIZE 58 EUDAMED
- Model / Reference
- HIPEX Ti PLASMA ACETABULAR SHELL CEMENTLESS SIZE 58 EUDAMED09.2158 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659068038 EUDAMED
- Basic UDI-DI
- B-05051659068038 EUDAMED
- EMDN Code
- P090803010201 PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS 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
HIPEX Ti PLASMA ACETABULAR SHELL CEMENTLESS SIZE 58 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-05051659068038 | 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 a81ee5c5-9486-4979-a470-9e45c93311ed 61 fields · synced Jul 16, 2026