SVL - Insert, 2R-12
by BEZNOSKA, s.r.o. EUDAMED
Active
Ref 358053
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number859260202001EW | Date21 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2026-MDR/QS-018 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 5 Mar 2026
- Expires
- 5 Mar 2031
- 2026-MDR/TD-018 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 5 Mar 2026
- Expires
- 5 Mar 2031
Specification
- Device Name
- Knee Replacement Systems and Ancillary Elements for Knee Replacement
- Model / Reference
- 358053
- Primary DI / UDI-DI
- 08592602125837
- Basic UDI-DI
- 859260202001EW
- EMDN Code
- P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
- Device Class
- Class III
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000000543
Other devices from BEZNOSKA, s.r.o.
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No