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Knee prosthesis -tibial insert
EUDAMEDClass III (EU MDR)
Ref A5300-0415RModel RY C403 / M4#-15mmR
Identity
- Device Name
- Knee prosthesis -tibial insert EUDAMED
- Model / Reference
- RY C403 / M4#-15mmR EUDAMEDA5300-0415R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942494904324 EUDAMED
- Basic UDI-DI
- B-06942494904324 EUDAMED
- EMDN Code
- P090903020202 BICOMPARTMENTAL PRIMARY IMPLANT 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-06942494904324 | 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 43ba2107-b4c7-4c0a-835e-22012f243f8c 61 fields · synced Aug 4, 2026