EUDAMED device

Mark 5 Nuvo Lite

EUDAMED device 00038214000035 · Nidek Medical Products Inc.

Key facts

Primary DI 00038214000035
Trade name Mark 5 Nuvo Lite
Device name Mark 5 Nuvo Lite
Reference or catalog number 925
Model 925
Manufacturer Nidek Medical Products Inc.
Manufacturer SRN US-MF-000007253
Risk class Class IIa
EMDN code Z12159004
EMDN description OXYGEN CONCENTRATORS
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Oct 21, 2021

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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