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Knee prosthesis -tibial insert
EUDAMEDClass III (EU MDR)
Ref A5300-0611RModel RY C403 / M6#-11mmR
Identity
- Device Name
- Knee prosthesis -tibial insert EUDAMED
- Model / Reference
- RY C403 / M6#-11mmR EUDAMEDA5300-0611R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942494904430 EUDAMED
- Basic UDI-DI
- B-06942494904430 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
This knee prosthesis -tibial insert is a medical device designed to provide stable and comfortable support for patients with knee injuries or conditions. Made from advanced materials, this device offers improved mobility, reduced pain, and enhanced overall quality of life for users.
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-06942494904430 | 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 095a9d0a-37a7-45f5-8827-07cf570600d1 61 fields · synced Oct 6, 2026