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Engage

FDA UDI

Class II (US FDA UDI)

by Hearing Lab Technology, Llc

Identity

Trade Name
Engage FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-the-ear FDA UDI
Device Name
ENGAGE BTE RECHARGEABL BEIGE ANDROID PKG FDA UDI
Model / Reference
7495 FDA UDI
Description
ENGAGE BTE RECHARGEABL BEIGE ANDROID PKG FDA UDI

Identifiers

Catalog Number
LA-EGBTE1-A-BG FDA UDI
Primary DI / UDI-DI
00812944027377 FDA UDI
FDA Product Code
OSM FDA UDI
GMDN Term
Air-conduction hearing aid, receiver-in-the-ear 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Air-conduction hearing aid, receiver-in-the-ear

Engage by Hearing Lab Technology, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, receiver-in-the-ear.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hearing Lab Technology, Llc

Sources (1)

  • FDA UDI 0b972eb2-634c-47f9-b204-d6e2f034c562 35 fields · synced Jun 1, 2026