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Ancale Tibial Component Cemented Size 8
EUDAMEDClass III (EU MDR)
Ref 02.0243Model ANCALE TIBIAL COMPONENT CEMENTED SIZE 8
Identity
- Trade Name
- ANCALE TIBIAL COMPONENT CEMENTED SIZE 8 EUDAMED
- Device Name
- ANCALE TIBIAL COMPONENT CEMENTED SIZE 8 EUDAMED
- Model / Reference
- ANCALE TIBIAL COMPONENT CEMENTED SIZE 8 EUDAMED02.0243 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659179321 EUDAMED
- Basic UDI-DI
- B-05051659179321 EUDAMED
- EMDN Code
- P090903020104 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FIXED BEARING TIBIAL PLATES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
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
Ancale Tibial Component Cemented Size 8 by Covision Medical Technologies 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-05051659179321 | Class III | 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 (1)
- EUDAMED 2f3708ad-e3a4-4232-b609-1b0c2f3fc8c0 61 fields · synced Aug 4, 2026