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Knee prosthesis- tibial insert
EUDAMEDClass III (EU MDR)
Ref A5301-0312RMModel DD 01 / 3#-12mmRM/LL
Identity
- Device Name
- Knee prosthesis- tibial insert EUDAMED
- Model / Reference
- DD 01 / 3#-12mmRM/LL EUDAMEDA5301-0312RM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942494906137 EUDAMED
- Basic UDI-DI
- B-06942494906137 EUDAMED
- EMDN Code
- P090904020202 UNICOMPARTMENTAL KNEE PROSTHESES TIBIAL INSERTS, FIXED 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-06942494906137 | 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 c95d58a4-09a6-4129-a65c-e6e64cd7e45b 61 fields · synced Sep 17, 2026