Identity
- Device Name
- Sanatyl, sterilní EUDAMED
- Model / Reference
- 0312/S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595154114434 EUDAMED
- Basic UDI-DI
- 859515412SANATYLZ2 EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE 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
Sanatyl, sterilní 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 | 859515412SANATYLZ2 | Class I | Active |
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Manufacturer
- Manufacturer
- STERIWUND spol. s r.o.
- EUDAMED SRN
- CZ-MF-000036963
Sources (1)
- EUDAMED de4923df-2966-4246-a95b-cb196d490d97 61 fields · synced Jun 19, 2026