Identity
- Trade Name
- OXYWISE EUDAMED
- Device Name
- Medical Oxygen Generator EUDAMED
- Model / Reference
- O35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588009198116 EUDAMED
- Basic UDI-DI
- B-08588009198116 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovakia 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
Category: Pulmonary function analysis system, adult
Oxywise by OXYWISE, s.r.o. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08588009198116 | Class IIb | Active |
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Manufacturer
- Manufacturer
- OXYWISE, s.r.o.
- EUDAMED SRN
- SK-MF-000034288
Sources (1)
- EUDAMED 25fab3f7-503b-45a2-842e-9581654d48ac 61 fields · synced Jul 26, 2026