Tobii Dynavox

FDA UDI

Class II (US FDA UDI)

by Tobii Dynavox LLC

Identity

Trade Name: Tobii Dynavox FDA UDI
Generic Name: Voice synthesizer/digitizer FDA UDI
Device Name: USB-C AC Adaptor for Tobii Dynavox Devices. Medical grade/certified to IEC 60601 and UL Approved. Fits all Navio Devices, TD I-110. FDA UDI
Model / Reference: NGE60-TD FDA UDI
Description: USB-C AC Adaptor for Tobii Dynavox Devices. Medical grade/certified to IEC 60601 and UL Approved. Fits all Navio Devices, TD I-110. FDA UDI

Identifiers

Catalog Number: 521100 FDA UDI
Primary DI / UDI-DI: 07340074602124 FDA UDI
FDA Product Code: ILQ FDA UDI
GMDN Term: Voice synthesizer/digitizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.3710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Voice synthesizer/digitizer

A comprehensive assistive device designed to deliver voice output based on previously-recorded natural speech or an electronic synthesized voice following a pre-established set of pronunciation rules. It is typically customized to meet the user's needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Tobii Dynavox LLC

Sources (1)

FDA UDI 3089f3e1-53d2-4204-9f9a-ff9f897c3cc2 36 fields · synced Jul 18, 2026