Identity
- Device Name
- SONOGEL - gel pro ultrasonografii EUDAMED
- Model / Reference
- 2728 EUDAMED2729 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595154110368 EUDAMED08595154110047 EUDAMED
- Basic UDI-DI
- 85951541018VP EUDAMED
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
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
SONOGEL - gel pro ultrasonografii 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 | 85951541018VP | Class I | Active |
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Manufacturer
- Manufacturer
- STERIWUND spol. s r.o.
- EUDAMED SRN
- CZ-MF-000036963
Sources (2)
- EUDAMED 8c3c565a-c096-4824-9326-f5f0b1a6c8ae 61 fields · synced Jul 14, 2026
- EUDAMED 860782ee-7912-408f-a5f1-1ecd560ea514 61 fields · synced May 17, 2026