← Back to catalogue
Mark 5 Nuvo Lite
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 925UKModel 925Ref 925-OCSI510(k) K123738Ref 965
Identity
- Trade Name
- Mark 5 Nuvo Lite EUDAMEDFDA UDIMark 5 Nuvo EUDAMED
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- Mark 5 Nuvo Lite EUDAMEDNidek Medical Oxygen Concentrators EUDAMED230V/50HZ OCSI OXYGEN CONCENTRATOR - PRIVATE LABELED FOR CLEANETICA FDA UDI230V/50HZ OCSI OXYGEN CONCENTRATOR - EURO PLUG FDA UDI230V/50HZ OCSI OXYGEN CONCENTRATOR -- UK PLUG FDA UDI
- Model / Reference
- 925 EUDAMEDFDA UDI925UK EUDAMEDFDA UDI925-OCSI EUDAMEDFDA UDI965 EUDAMED
- Description
- 230V/50HZ OCSI OXYGEN CONCENTRATOR - PRIVATE LABELED FOR CLEANETICA FDA UDI230V/50HZ OCSI OXYGEN CONCENTRATOR - EURO PLUG FDA UDI230V/50HZ OCSI OXYGEN CONCENTRATOR -- UK PLUG FDA UDI
Identifiers
- Catalog Number
- 925-OCSI FDA UDI925 FDA UDI925UK FDA UDI
- Primary DI / UDI-DI
- 00038214001179 EUDAMEDFDA UDI00038214001520 EUDAMEDFDA UDI00038214002923 EUDAMED00038214000035 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00038214001179 EUDAMED00038214NIDEK4L EUDAMEDB-00038214000035 EUDAMED
- Direct Marketing DI
- 00038214001520 EUDAMED00038214002923 EUDAMED00038214000035 EUDAMED00038214001179 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 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 by Nidek Medical Products Inc. — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123738 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00038214001179 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-00038214001179 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nidek Medical Products Inc.
- EUDAMED SRN
- US-MF-000007253
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (10)
- EUDAMED 6581723d-9078-49a3-9097-cb2ab48d76f8 61 fields · synced Oct 6, 2026
- EUDAMED 9806701a-26f0-4bf2-8219-6dd600814b08 85 fields · synced May 16, 2026
- EUDAMED b18425c3-0298-4df4-813c-36221038c73e 61 fields · synced May 17, 2026
- EUDAMED 0ca3a16c-a7a3-4765-af97-5567b3302f48 61 fields · synced May 18, 2026
- FDA UDI 63351c5a-63a8-48bb-8f14-bb4097e746a3 37 fields · synced May 30, 2026
- FDA UDI 1d3feb43-b630-4fe2-80e2-634770616566 37 fields · synced May 30, 2026
- FDA UDI d593e84c-83df-449e-8e9b-2b365a1a2fb4 37 fields · synced May 30, 2026
- EUDAMED bbf6aa96-1e71-4d95-a449-6c0d0bcd8a87 61 fields · synced Jul 20, 2026
- EUDAMED 6581723d-9078-49a3-9097-cb2ab48d76f8 61 fields · synced Jul 21, 2026
- FDA 510(k) K123738 1 fields · synced May 18, 2026