Identity
- Trade Name
- SVL/RP - Insert, 2R-10 EUDAMED
- Device Name
- KNEE REPLACEMENT SYSTEMS AND ANCILLARY ELEMENTS FOR KNEE REPLACEMENT EUDAMED
- Model / Reference
- 356412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602124991 EUDAMED
- Basic UDI-DI
- 859260202001EW EUDAMED
- EMDN Code
- P090903020201 BICOMPARTMENTAL PRIMARY IMPLANT MOBILE BEARING TIBIAL INSERTS 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
SVL/RP - Insert, 2R-10 by BEZNOSKA, s.r.o. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED f10fe6ce-9c26-4be6-9a2d-37747fa75c2c 61 fields · synced Sep 17, 2026