Identity
- Trade Name
- O•ZONE oil EUDAMED
- Device Name
- Oleogel EUDAMED
- Model / Reference
- 0351 EUDAMED0350 EUDAMED0345 EUDAMED0369 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595154115677 EUDAMED08595154115660 EUDAMED08595154115653 EUDAMED08595154115684 EUDAMED
- Basic UDI-DI
- 85951541022VE EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) 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
O•ZONE oil 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 | 85951541022VE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- STERIWUND spol. s r.o.
- EUDAMED SRN
- CZ-MF-000036963
Sources (4)
- EUDAMED c9997801-329d-42b3-8296-41ae76d9060f 61 fields · synced Aug 2, 2026
- EUDAMED 4088ef28-7e81-4934-9347-4d9c139070e9 61 fields · synced May 17, 2026
- EUDAMED c4c90a25-f287-4ec8-a5f8-c07f6579a343 61 fields · synced May 17, 2026
- EUDAMED bffb4a6f-ceae-441c-ad95-9fc80c1107e6 61 fields · synced May 18, 2026