Identity
- Trade Name
- Rouška z netkané textilie EUDAMED
- Device Name
- Roušky, sterilní EUDAMED
- Model / Reference
- 0458 EUDAMED0479 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595154107115 EUDAMED08595154104824 EUDAMED
- Basic UDI-DI
- 859515407ROUSKAY3 EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Rouška z netkané textilie by STERIWUND spol. s r.o. — Class I — 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 | 859515407ROUSKAY3 | Class I | Active |
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Manufacturer
- Manufacturer
- STERIWUND spol. s r.o.
- EUDAMED SRN
- CZ-MF-000036963
Sources (2)
- EUDAMED 262c736b-a182-4f8e-a730-8d7282dd073b 61 fields · synced Jul 26, 2026
- EUDAMED 76c899c9-1c74-493e-af66-315061ff38f4 61 fields · synced May 18, 2026