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Hipex
EUDAMEDClass III (EU MDR)
Ref 09.2800Model XL-UHMWPE ACETABULAR LINER 0 DEG. Ø 22 FOR SIZE 38-40 (GROUP 0)
Identity
- Trade Name
- HIPEX EUDAMED
- Device Name
- HIPEX EUDAMED
- Model / Reference
- XL-UHMWPE ACETABULAR LINER 0 DEG. Ø 22 FOR SIZE 38-40 (GROUP 0) EUDAMED09.2800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659068489 EUDAMED
- Basic UDI-DI
- B-05051659068489 EUDAMED
- EMDN Code
- P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES INSERTS 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: Non-constrained polyethylene acetabular liner
Hipex by Covision Medical Technologies Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Non-constrained polyethylene acetabular liner.
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- PINNACLE — DEPUY ORTHOPAEDICS, INC. · 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-05051659068489 | 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 cfdeca86-7592-4b3a-8e0d-ea06b084d738 61 fields · synced Jun 17, 2026