Annidis Health Systems Corp

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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

Camera, Ophthalmic, Ac-Powered (HKI) (1) Ophthalmoscope, Ac-Powered (HLI) (1)

Premarket Exempt

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RHA - 00627843652021 Catalog Number :

Device Description : The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to captu The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.

Device Class : 2

Duns Number: 243651440

Premarket Exempt : No

Product Code : HKI, HLI

Prescription Use : No

Device Count : 1

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