Chat Point

FDA UDI

Class II (US FDA UDI)

by Prentke Romich Company

Identity

Trade Name: Chat Point FDA UDI
Generic Name: Voice synthesizer/digitizer FDA UDI
Device Name: Head pointing for Chat Fusion FDA UDI
Model / Reference: CP FDA UDI
Description: Head pointing for Chat Fusion FDA UDI

Identifiers

Primary DI / UDI-DI: 00816486020001 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

Yes

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Voice synthesizer/digitizer

Chat Point by Prentke Romich Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Prentke Romich Company

Sources (1)

FDA UDI 2db57a42-3d91-4656-bd65-9c5c8e3d2fec 34 fields · synced May 30, 2026