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Eflecto Tibial Insert Highly Crosslink (xl) Size 5 X 21 Mm
EUDAMEDClass III (EU MDR)
Ref 01.9811Model EFLECTO TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 5 X 21 MM
Identity
- Trade Name
- EFLECTO TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 5 X 21 MM EUDAMED
- Device Name
- EFLECTO TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 5 X 21 MM EUDAMED
- Model / Reference
- EFLECTO TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 5 X 21 MM EUDAMED01.9811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659177877 EUDAMED
- Basic UDI-DI
- B-05051659177877 EUDAMED
- EMDN Code
- P090905020202 REVISION KNEE PROSTHESES 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
Eflecto Tibial Insert Highly Crosslink (xl) Size 5 X 21 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-05051659177877 | 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 4eb24544-04d5-46d4-8f09-67d75f269586 61 fields · synced Oct 6, 2026