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Reflecto Tibial Insert Highly Crosslink (xl) Size 1 X 9 Mm
EUDAMEDClass III (EU MDR)
Ref 01.9778Model REFLECTO TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 1 X 9 MM
Identity
- Trade Name
- REFLECTO TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 1 X 9 MM EUDAMED
- Device Name
- REFLECTO TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 1 X 9 MM EUDAMED
- Model / Reference
- REFLECTO TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 1 X 9 MM EUDAMED01.9778 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659177549 EUDAMED
- Basic UDI-DI
- B-05051659177549 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
Reflecto Tibial Insert Highly Crosslink (xl) Size 1 X 9 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-05051659177549 | 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 ac49f446-38b9-4645-9c65-4d716add21d1 61 fields · synced Jul 24, 2026