HEARX GROUP (PTY) LTD

Address:Building 2, Ashlea Gardens Office Park,Pretoria Gauteng,ZA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Hearing Aid, Air Conduction With Wireless Technology (OSM) (4) Self-Fitting Air-Conduction Hearing Aid (QDD) (4) Hearing Aid, Air Conduction (ESD) (2)

Premarket Exempt

No Yes

Clear

Lexie Hearing - 00850022464003 Catalog Number : Lumen 155

Device Description : Lexie Lumen self-fitting Silver hearing aid - Duo

Device Class : 2

Duns Number: 539177681

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Lexie Hearing - 00850022464256 Catalog Number : Lexie Android App

Device Description : Android Hearing Aid Programming App

Device Class : 2

Duns Number: 539177681

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Lexie Hearing - 00850022464263 Catalog Number : Lexie iOS App

Device Description : iOS Hearing Aid Programming App

Device Class : 2

Duns Number: 539177681

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Go Hearing - 00850022464454 Catalog Number :

Device Description : These hearing aids are for users age 18 and older to compensate for perceived mi These hearing aids are for users age 18 and older to compensate for perceived mild-to-moderate hearing impairment.

Device Class : 1

Duns Number: 539177681

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Go Hearing - 00850022464461 Catalog Number :

Device Class : 1

Duns Number: 539177681

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Lexie B1, Powered by Bose - 00850022464492 Catalog Number : Online

Device Description : Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids

Device Class : 2

Duns Number: 539177681

Premarket Exempt : No

Product Code : QDD

Prescription Use : No

Device Count : 1

Lexie Hearing - 00850022464577 Catalog Number : In-Store

Device Description : Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids

Device Class :

Duns Number: 539177681

Premarket Exempt : No

Product Code : QDD

Prescription Use : No

Device Count : 1

Lexie B2, Powered by Bose - 00850022464638 Catalog Number : LBO00001B2

Device Description : Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid

Device Class : 2

Duns Number: 539177681

Premarket Exempt : No

Product Code : QDD

Prescription Use : No

Device Count : 1

Lexie Hearing - 00850022464645 Catalog Number : In-Store

Device Description : Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid

Device Class : 2

Duns Number: 539177681

Premarket Exempt : No

Product Code : QDD

Prescription Use : No

Device Count : 1

Lexie Hearing - 00860003469804 Catalog Number : Lumen 155

Device Description : Lexie Lumen self-fitting Beige hearing aid - Duo

Device Class : 2

Duns Number: 539177681

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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