Identity
- Trade Name
- AUDIXOL OXI CLEAN SPRAY 30 ML EUDAMED
- Device Name
- AUDIXOL OXI CLEAN SPRAY 30 ML EUDAMED
- Model / Reference
- 60000344 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594189200822 EUDAMED
- Basic UDI-DI
- B-08594189200822 EUDAMED
- EMDN Code
- Q03040299 EAR IRRIGATION DEVICES - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Audixol Oxi Clean Spray 30 Ml by Društvo za proizvodnju i promet Esensa d.o.o. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08594189200822 | Class I | Active |
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Manufacturer
- Manufacturer
- Društvo za proizvodnju i promet Esensa d.o.o.
- EUDAMED SRN
- RS-MF-000031288
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED 94c161d2-bcc7-4af4-99d4-a421efc56c50 61 fields · synced Jul 14, 2026