Identity
- Trade Name
- Acetabular Component EUDAMED
- Device Name
- Sterile Hip Prosthesis EUDAMED
- Model / Reference
- F13AB-PA00614 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512036198 EUDAMED
- Basic UDI-DI
- B-06942512036198 EUDAMED
- EMDN Code
- P0908030602 PRE-ASSEMBLED ACETABULAR COMPONENTS WITH POLYETHYLENE INSERTS 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
Acetabular Component by Wuhan Mindray Scientific Co., 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-06942512036198 | 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 4d9985f1-5d64-40d3-b4ff-494814ba4a83 61 fields · synced Jun 18, 2026