Identity
- Trade Name
- Mark 5 Nuvo Lite 3 EUDAMEDMARK 5 NUVO LITE3 FDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- Nidek Medical Oxygen Concentrators EUDAMED230V/50HZ OCSI OXYGEN CONCENTRATOR FDA UDI
- Model / Reference
- 935 EUDAMEDFDA UDI
- Description
- 230V/50HZ OCSI OXYGEN CONCENTRATOR FDA UDI
Identifiers
- Catalog Number
- 935 FDA UDI
- Primary DI / UDI-DI
- 00038214000080 EUDAMEDFDA UDI
- Basic UDI-DI
- 00038214NIDEK4L EUDAMED
- Direct Marketing DI
- 00038214000080 EUDAMED
- 510(k) Number
- K123738 FDA UDI
- FDA Product Code
- CAW FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Stationary oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mark 5 Nuvo Lite 3 by Nidek Medical Products Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00038214NIDEK4L | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nidek Medical Products Inc.
- EUDAMED SRN
- US-MF-000007253
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 5112735f-0966-4b9c-91e7-a10c1b7763c9 61 fields · synced Oct 6, 2026
- FDA UDI 69c1325a-a7fd-4965-a930-54702d9366d3 37 fields · synced May 30, 2026