Identity
- Trade Name
- Mark 5 Nuvo Lite EUDAMED
- Device Name
- Nidek Medical Oxygen Concentrators EUDAMED
- Model / Reference
- 925Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00038214000974 EUDAMED
- Basic UDI-DI
- 00038214NIDEK4L EUDAMED
- Direct Marketing DI
- 00038214000974 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
Mark 5 Nuvo Lite by Nidek Medical Products Inc. — 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 | 00038214NIDEK4L | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nidek Medical Products Inc.
- EUDAMED SRN
- US-MF-000007253
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED b2fee901-40ab-4ec5-9544-a1f19b733dfd 61 fields · synced May 23, 2026