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Unitron

FDA UDI

Class II (US FDA UDI)

by Unitron Hearing Division

Identity

Trade Name
UNITRON FDA UDI
Generic Name
Hearing aid enhanced audio device, telecommunication/multimedia FDA UDI
Device Name
uDirect, Incl. US Power Supply FDA UDI
Model / Reference
076-5001-0011 FDA UDI
Description
uDirect, Incl. US Power Supply FDA UDI

Identifiers

Catalog Number
076-5001-0011 FDA UDI
Primary DI / UDI-DI
00698764302210 FDA UDI
FDA Product Code
OSM FDA UDI
GMDN Term
Hearing aid enhanced audio device, telecommunication/multimedia FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3305 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
MRI Safety
MR Unsafe FDA UDI

Category: Hearing aid enhanced audio device, telecommunication/multimedia

Unitron by Unitron Hearing Division — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hearing aid enhanced audio device, telecommunication/multimedia.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unitron Hearing Division

Sources (1)

  • FDA UDI 491fc71a-7adb-4d13-9a65-a3db9ea1f428 35 fields · synced May 30, 2026