Identity
- Trade Name
- Oxygen Mixer EUDAMED
- Device Name
- Ventway Sparrow Oxygen Mixer EUDAMED
- Model / Reference
- VWSP-470 EUDAMEDVWSP-580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290017096374 EUDAMED
- Basic UDI-DI
- 7290017096VentwayOMZR EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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
Category: Pulmonary function analysis system, adult
Oxygen Mixer by Inovytec Medical Solutions Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7290017096VentwayOMZR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Inovytec Medical Solutions Ltd.
- EUDAMED SRN
- IL-MF-000034055
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 538afbcd-5af9-4cbc-a163-b709b5b9399a 61 fields · synced Jul 9, 2026