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Knee prosthesis tibial insert
EUDAMEDClass III (EU MDR)
Ref 52003-3-15Model RY C402 / 3#/15mm
Identity
- Device Name
- Knee prosthesis tibial insert EUDAMED
- Model / Reference
- RY C402 / 3#/15mm EUDAMED52003-3-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942494908001 EUDAMED
- Basic UDI-DI
- B-06942494908001 EUDAMED
- EMDN Code
- P090905020202 REVISION KNEE PROSTHESES FIXED BEARING TIBIAL INSERTS 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 tibial insert 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-06942494908001 | 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 1d0cc242-cf00-4ca5-8bb7-42ccf5a5dd6f 61 fields · synced Sep 18, 2026