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Acetabular Insert
EUDAMEDClass III (EU MDR)
Ref J2037-1-4428Ref J2037-1-4228Ref J2037-1-4828Ref J2037-1-4628Ref J2037-1-3424
Identity
- Trade Name
- Acetabular Insert EUDAMED
- Device Name
- Sterile Hip Prosthesis EUDAMED
- Model / Reference
- J2037-1-4428 EUDAMEDJ2037-1-4228 EUDAMEDJ2037-1-4828 EUDAMEDJ2037-1-4628 EUDAMEDJ2037-1-3424 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512017128 EUDAMED06942512017111 EUDAMED06942512017142 EUDAMED06942512017135 EUDAMED06942512032756 EUDAMED
- Basic UDI-DI
- B-06942512017128 EUDAMEDB-06942512017111 EUDAMEDB-06942512017142 EUDAMEDB-06942512017135 EUDAMEDB-06942512032756 EUDAMED
- EMDN Code
- P090803040103 RETENTIVE POLYETHYLENE HIP PROSTHESES INSERTS, ANTI-DISLOCATION EUDAMEDP090803010201 PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS 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-06942512017128 | 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 (5)
- EUDAMED e9791ef2-246f-48c6-a5e5-167b7cddf6ed 61 fields · synced Jul 29, 2026
- EUDAMED 7bd18fdf-104a-4db2-83ee-c9f620d61b82 61 fields · synced May 16, 2026
- EUDAMED 40d705be-d37f-49d1-9584-6e6c70578c1a 61 fields · synced May 17, 2026
- EUDAMED e7d33fb4-9c36-4597-900b-0df1afc38e65 61 fields · synced May 18, 2026
- EUDAMED 5d099493-ebc5-435d-8a0f-efd08b8dc13c 61 fields · synced May 19, 2026