Identity
- Trade Name
- CMS - Hinge, 2/12 EUDAMED
- Device Name
- KNEE REPLACEMENT SYSTEMS AND ANCILLARY ELEMENTS FOR KNEE REPLACEMENT EUDAMED
- Model / Reference
- 341565 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602122928 EUDAMED
- Basic UDI-DI
- 859260202001EW EUDAMED
- EMDN Code
- P09098002 KNEE PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Knee arthroplasty wedge
CMS - Hinge, 2/12 by BEZNOSKA, s.r.o. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Knee arthroplasty wedge.
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- LEGION — Smith & Nephew, Inc. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 859260202001EW | Class III | Active |
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Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED 3714d8b1-7321-407d-8ea4-29b82018dc10 61 fields · synced Sep 18, 2026