Identity
- Trade Name
- Acetabular Insert EUDAMED
- Device Name
- Sterile Hip Prosthesis EUDAMED
- Model / Reference
- J2037-1-3824 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512017098 EUDAMED
- Basic UDI-DI
- B-06942512017098 EUDAMED
- EMDN Code
- P090803040103 RETENTIVE POLYETHYLENE HIP PROSTHESES INSERTS, ANTI-DISLOCATION EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Acetabular Insert by Wuhan Mindray Scientific Co., 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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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-06942512017098 | Class III | Active |
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Manufacturer
- Manufacturer
- Wuhan Mindray Scientific Co., Ltd.
- EUDAMED SRN
- CN-MF-000032692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fe6a1a34-e104-4829-bc85-2dc56a6a6793 61 fields · synced Jun 18, 2026