Identity
- Trade Name
- OXYWISE EUDAMED
- Device Name
- Medical Oxygen Generator EUDAMED
- Model / Reference
- O15 EUDAMEDO1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588009198062 EUDAMED
- Basic UDI-DI
- B-08588009198062 EUDAMED085880091980MEDGENEB EUDAMED
- Direct Marketing DI
- 08588009198062 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
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
Oxywise by OXYWISE, s.r.o. — Class IIb — MDR, 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/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08588009198062 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08588009198062 | Class IIb | Active |
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Manufacturer
- Manufacturer
- OXYWISE, s.r.o.
- EUDAMED SRN
- SK-MF-000034288
Sources (2)
- EUDAMED d3f2bf46-36ed-465e-9c9a-13aaeba42f18 61 fields · synced Jun 18, 2026
- EUDAMED 3ecd4b8e-3678-4a2c-97cd-d22a7c96fd62 61 fields · synced Jun 18, 2026