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

Audiometer (EWO) (1) Otoscope (ERA) (1)

Premarket Exempt

No Yes

Clear

hearX - 00860003469811 Catalog Number :

Device Class : 2

Duns Number: 539177681

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

hearX - 00860003469828 Catalog Number :

Device Description : hearScope consists of a handheld video otoscope with a light source and ear spec hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).

Device Class : 1

Duns Number: 539177681

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

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