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Ancale Cs Tibial Insert Highly Crosslink (xl) Size 4-11 Mm
EUDAMEDClass III (EU MDR)
Ref 02.0402Model ANCALE CS TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 4-11 MM
Identity
- Trade Name
- ANCALE CS TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 4-11 MM EUDAMED
- Device Name
- ANCALE CS TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 4-11 MM EUDAMED
- Model / Reference
- ANCALE CS TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 4-11 MM EUDAMED02.0402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659180914 EUDAMED
- Basic UDI-DI
- B-05051659180914 EUDAMED
- EMDN Code
- P090903020202 BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS 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 Cs Tibial Insert Highly Crosslink (xl) Size 4-11 Mm by Covision Medical Technologies Ltd. — Class III — MDD — listed in EUDAMED
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-05051659180914 | 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 d2042e35-c455-4794-b982-e789049d4e4f 61 fields · synced Jun 19, 2026