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SPEAX Patch

FDA UDI

Class II (US FDA UDI)

by Ataia Inc.

Identity

Trade Name
SPEAX Patch FDA UDI
Generic Name
Voice amplification system FDA UDI
Device Name
Patch for use with the SPEAX Communication System FDA UDI
Model / Reference
FGN-002 FDA UDI
Description
Patch for use with the SPEAX Communication System FDA UDI

Identifiers

Catalog Number
FGN002 FDA UDI
Primary DI / UDI-DI
B792FGN002 FDA UDI
FDA Product Code
ILQ FDA UDI
GMDN Term
Voice amplification system 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Voice amplification system

SPEAX Patch by Ataia Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Voice amplification system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ataia Inc.

Sources (1)

  • FDA UDI 373849ec-060f-466d-b4c9-858e9ea0b11f 36 fields · synced Jun 8, 2026