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Knee prosthesis- femoral condyle
EUDAMEDClass III (EU MDR)
Ref 51501-1Model XR A301 / 1L
Identity
- Device Name
- Knee prosthesis- femoral condyle EUDAMED
- Model / Reference
- XR A301 / 1L EUDAMED51501-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942494906397 EUDAMED
- Basic UDI-DI
- B-06942494906397 EUDAMED
- EMDN Code
- P09090501 REVISION KNEE PROSTHESES FEMORAL COMPONENTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Knee prosthesis- femoral condyle by Beijing LiDaKang Technology 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-06942494906397 | Class III | Active |
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Manufacturer
- Manufacturer
- Beijing LiDaKang Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027201
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fcf4184b-6c36-45b0-a8c2-c0290b53ad9f 61 fields · synced Oct 6, 2026