Identity
- Trade Name
- PRIZMA O2 EUDAMED
- Device Name
- PRIZMA O2 EUDAMED
- Model / Reference
- PRIZMA O2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08606111792555 EUDAMED
- Basic UDI-DI
- 8606111792O2EV EUDAMED
- Direct Marketing DI
- 08606111792555 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Prizma O2 by Prizma Kragujevac Doo — Class IIb — 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 | 8606111792O2EV | Class IIb | Active |
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Manufacturer
- Manufacturer
- Prizma Kragujevac Doo
- EUDAMED SRN
- RS-MF-000037752
- Authorised Representative
- Prizma GmbH DE-AR-000037217
Sources (1)
- EUDAMED fd89eecd-35b0-4f02-9b14-30e634c93ee2 61 fields · synced Jun 18, 2026