Identity
- Trade Name
- SVR II - Trial shaped tibial aug., 4L-10 EUDAMED
- Device Name
- Reusable surgical instruments EUDAMED
- Model / Reference
- 308831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602248147 EUDAMED
- Basic UDI-DI
- 859260200001EG EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
The SVR II - Trial shaped tibial aug., 4L-10 device is a reusable surgical instrument designed for orthopedic applications. Made from high-quality materials, this implantable medical device features a unique design that allows for easy maneuverability and precision.
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 | 859260200001EG | Class I | Active |
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Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED d8bf7c3e-96a2-4d65-9d41-21d8c6f34dfd 61 fields · synced Aug 4, 2026