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ELEHEAR Alpha

FDA UDI

Class I (US FDA UDI)

by Elevoc Technology Co., Ltd.

Identity

Trade Name
ELEHEAR Alpha FDA UDI
Generic Name
Air-conduction hearing aid, wearable case FDA UDI
Model / Reference
RIC 02 FDA UDI

Identifiers

Primary DI / UDI-DI
69743465514172 FDA UDI
FDA Product Code
QUF FDA UDI
GMDN Term
Air-conduction hearing aid, wearable case FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.3300 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Air-conduction hearing aid, wearable case

ELEHEAR Alpha by Elevoc Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, wearable case.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elevoc Technology Co., Ltd.

Sources (1)

  • FDA UDI 5b979826-ae57-4b0a-943e-665e37e45f5e 33 fields · synced May 30, 2026