Identity
- Trade Name
- Mark 5 Nuvo Lite EUDAMEDFDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- Mark 5 Nuvo Lite EUDAMED230V/50HZ OCSI OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE FDA UDI
- Model / Reference
- 925 EUDAMED925GC EUDAMEDFDA UDI
- Description
- 230V/50HZ OCSI OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE FDA UDI
Identifiers
- Catalog Number
- 925GC FDA UDI
- Primary DI / UDI-DI
- 00038214000929 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00038214000929 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 IIa 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
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
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 by Nidek Medical Products Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00038214000929 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 edc5576e-246c-4a4c-ad40-8f516c27d355 61 fields · synced Jul 17, 2026
- FDA UDI 6bf6db77-495b-4f91-84c8-f9d328d9eef7 37 fields · synced May 30, 2026