← Back to catalogue

Lingraphica

FDA UDI

Class II (US FDA UDI)

by Lingraphicare America, Inc.

Identity

Trade Name
Lingraphica FDA UDI
Generic Name
Voice synthesizer/digitizer FDA UDI
Device Name
Speech Generating Device - Lenovo Yoga 13 - 13.3" FDA UDI
Model / Reference
AllTalk FDA UDI
Description
Speech Generating Device - Lenovo Yoga 13 - 13.3" FDA UDI

Identifiers

Primary DI / UDI-DI
00850042278192 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

Yes

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

No

FDA UDI

Category: Voice synthesizer/digitizer

Lingraphica by Lingraphicare America, Inc. — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Lingraphicare America, Inc.

Sources (1)

  • FDA UDI 478aa619-3e4a-4325-b20c-72c6b480c45c 33 fields · synced Jun 8, 2026