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Covision
EUDAMEDClass I (EU MDR)
Ref 95.1601CModel REFLECTO REVISION KNEE SYSTEM INSTRUMENTS CASE 2Ref 01.5250NModel ST.LEGER NEO KNEE P/S FEMORAL COMPONENT CEMENTED LEFT 50mmRef 01.6457Model ST.LEGER NEO KNEE TIBIAL COMPONENT SIZE-50-55-60 STEM 70mm (TITANIUM)Ref 01.5050NModel ST.LEGER NEO KNEE C/R FEMORAL COMPONENT CEMENTED
Identity
- Trade Name
- COVISION EUDAMEDST.LEGER NEO KNEE EUDAMEDST.LEGER NEO KNEE TIBIAL COMPONENT SIZE-50-55-60 STEM 70mm (TITANIUM) EUDAMEDSt leger Neo Knee EUDAMED
- Device Name
- REFLECTO REVISION KNEE SYSTEM INSTRUMENTS CASE 2 EUDAMEDST.LEGER NEO KNEE P/S FEMORAL COMPONENT CEMENTED LEFT EUDAMEDST.LEGER NEO KNEE TIBIAL COMPONENT SIZE-50-55-60 STEM 70mm (TITANIUM) EUDAMEDST.LEGER NEO KNEE C/R FEMORAL COMPONENT CEMENTED LEFT 50mm EUDAMED
- Model / Reference
- REFLECTO REVISION KNEE SYSTEM INSTRUMENTS CASE 2 EUDAMED95.1601C EUDAMEDST.LEGER NEO KNEE P/S FEMORAL COMPONENT CEMENTED LEFT 50mm EUDAMED01.5250N EUDAMEDST.LEGER NEO KNEE TIBIAL COMPONENT SIZE-50-55-60 STEM 70mm (TITANIUM) EUDAMED01.6457 EUDAMEDST.LEGER NEO KNEE C/R FEMORAL COMPONENT CEMENTED EUDAMED01.5050N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659204672 EUDAMED05051659047323 EUDAMED05051659047804 EUDAMED05051659047224 EUDAMED
- Basic UDI-DI
- B-05051659204672 EUDAMEDB-05051659047323 EUDAMEDB-05051659047804 EUDAMEDB-05051659047224 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDP0909030101 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS EUDAMEDP090903020104 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FIXED BEARING TIBIAL PLATES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass III EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMEDEUDAMED
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Covision by Covision Medical Technologies Ltd. — Class I — 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-05051659204672 | Class I | Active |
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Manufacturer
- Manufacturer
- Covision Medical Technologies Ltd.
- EUDAMED SRN
- GB-MF-000025081
- Authorised Representative
- Covision Medical Technologies (Ireland) Limited IE-AR-000031129
Sources (4)
- EUDAMED 15d92b11-0666-4670-a047-53d1338428b3 61 fields · synced Oct 6, 2026
- EUDAMED 6baa6974-0cc0-45cb-9bb9-31357e24dc60 61 fields · synced May 18, 2026
- EUDAMED e55f38a8-bc78-44b0-adf2-6df36831c284 61 fields · synced May 18, 2026
- EUDAMED 2926c559-5377-4224-a23d-968ed0ec743d 61 fields · synced May 19, 2026