EUDAMED device

Mark 5 Nuvo 10

EUDAMED device 00038214001698 · Nidek Medical Products Inc.

Key facts

Primary DI 00038214001698
Trade name Mark 5 Nuvo 10
Device name Nidek Medical Oxygen Concentrators
Reference or catalog number 1005/60
Manufacturer Nidek Medical Products Inc.
Manufacturer SRN US-MF-000007253
Risk class Class IIb
EMDN code Z12159004
EMDN description OXYGEN CONCENTRATORS
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Feb 26, 2025

At a glance

  • No 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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