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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
SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iPad Mini. Small portable speech device for people who can not speak due to disability, injury or illness. High output speakers, durability and ingress protection for FDA UDI
Model / Reference
SC Tablet Mini FDA UDI
Description
SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iPad Mini. Small portable speech device for people who can not speak due to disability, injury or illness. High output speakers, durability and ingress protection for FDA UDI

Identifiers

Catalog Number
113527 FDA UDI
Primary DI / UDI-DI
07340074601929 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Voice synthesizer/digitizer

Tobii Dynavox by Tobii Dynavox LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Voice synthesizer/digitizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tobii Dynavox LLC

Sources (1)

  • FDA UDI f3d37956-452c-499a-9cb2-9384f8a39149 35 fields · synced Jun 8, 2026