EUDAMED device

Nova Chat 10.6 Keyguard 60 Location

EUDAMED device 00816486020841 · PRENTKE ROMICH COMPANY

Key facts

Primary DI 00816486020841
Trade name Nova Chat 10.6 Keyguard 60 Location
Device name NovaChat 5.4
Reference or catalog number 18182-60-A
Model NC5.4
Manufacturer PRENTKE ROMICH COMPANY
Manufacturer SRN US-MF-000018695
Risk class Class I
EMDN code Y214212
EMDN description VOICE GENERATORS
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Feb 23, 2023

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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