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NEOS Primary Stem
EUDAMEDClass III (EU MDR)
Ref F13AB-PA00607Ref F13AB-PA00605Ref F13AB-PA00603Ref F13AB-PA00606Ref F13AB-PA00609Ref F13AB-PA00608
Identity
- Trade Name
- NEOS Primary Stem EUDAMED
- Device Name
- Sterile Hip Prosthesis EUDAMED
- Model / Reference
- F13AB-PA00607 EUDAMEDF13AB-PA00605 EUDAMEDF13AB-PA00603 EUDAMEDF13AB-PA00606 EUDAMEDF13AB-PA00609 EUDAMEDF13AB-PA00608 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512036129 EUDAMED06942512036105 EUDAMED06942512036082 EUDAMED06942512036112 EUDAMED06942512036143 EUDAMED06942512036136 EUDAMED
- Basic UDI-DI
- B-06942512036129 EUDAMEDB-06942512036105 EUDAMEDB-06942512036082 EUDAMEDB-06942512036112 EUDAMEDB-06942512036143 EUDAMEDB-06942512036136 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
NEOS Primary 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-06942512036129 | 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 (6)
- EUDAMED b74967cb-0db1-445b-9422-3fd777309537 61 fields · synced Jul 25, 2026
- EUDAMED 06f440e8-2bc2-40b3-b8f6-c349f2624c14 61 fields · synced May 16, 2026
- EUDAMED e80344a3-c37a-4e48-a037-7a3475676d5c 61 fields · synced May 17, 2026
- EUDAMED 0fa84392-daf9-4856-bf29-399550f8b0ac 61 fields · synced May 18, 2026
- EUDAMED a1ece8c0-9173-4f61-899a-e8984c663c38 61 fields · synced May 19, 2026
- EUDAMED af75f135-2bcc-44a0-9a30-339add983bc0 61 fields · synced May 19, 2026