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Total Knee Replacement Set
EUDAMEDClass I (EU MDR)
Ref 498928Model Orthopedic Surgical Pack
Identity
- Trade Name
- Total Knee Replacement Set EUDAMED
- Device Name
- Orthopedic Surgical Pack EUDAMED
- Model / Reference
- Orthopedic Surgical Pack EUDAMED498928 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288667517 EUDAMED
- Basic UDI-DI
- 69562886JA0001K3 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Total Knee Replacement Set by Cobes Industries(Hefei) Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69562886JA0001K3 | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0fd5f336-dd63-4c0e-adf9-e909accc70ba 61 fields · synced Jun 17, 2026