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Wedge-shaped Stem
EUDAMEDClass III (EU MDR)
Ref F13AB-PA00639Ref F13AB-PA00638Ref F13AB-PA00633Ref F13AB-PA00635Ref F13AB-PA00641Ref F13AB-PA00632Ref F13AB-PA00634
Identity
- Trade Name
- Wedge-shaped Stem EUDAMED
- Device Name
- Sterile Hip Prosthesis EUDAMED
- Model / Reference
- F13AB-PA00639 EUDAMEDF13AB-PA00638 EUDAMEDF13AB-PA00633 EUDAMEDF13AB-PA00635 EUDAMEDF13AB-PA00641 EUDAMEDF13AB-PA00632 EUDAMEDF13AB-PA00634 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512036440 EUDAMED06942512036433 EUDAMED06942512036389 EUDAMED06942512036402 EUDAMED06942512036464 EUDAMED06942512036372 EUDAMED06942512036396 EUDAMED
- Basic UDI-DI
- B-06942512036440 EUDAMEDB-06942512036433 EUDAMEDB-06942512036389 EUDAMEDB-06942512036402 EUDAMEDB-06942512036464 EUDAMEDB-06942512036372 EUDAMEDB-06942512036396 EUDAMED
- EMDN Code
- P090804010201 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT 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
Wedge-shaped Stem 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-06942512036440 | 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 (7)
- EUDAMED cb8539cb-c7f6-4c88-9c6d-9540b1106ea7 61 fields · synced Sep 18, 2026
- EUDAMED 9f7a6bac-39ee-4651-b01e-69d2254add3a 61 fields · synced May 17, 2026
- EUDAMED 3a687d80-0cab-43e4-acf8-456f63075a7b 61 fields · synced May 18, 2026
- EUDAMED 11ac3458-3015-4448-b91c-82c23b4fb32c 61 fields · synced May 18, 2026
- EUDAMED f97886d6-b710-4103-85ea-da15c437389c 61 fields · synced May 18, 2026
- EUDAMED d344af10-2c18-436e-b54d-b9ce31af9b76 61 fields · synced May 18, 2026
- EUDAMED 11b19324-3e49-4c18-b118-84aa62d8a6fa 61 fields · synced May 19, 2026