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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) (2)

Premarket Exempt

Clear

NEXY - B667NEXY1 Catalog Number :

Device Description : Nexy device is an automatic eye-fundus camera intended for taking digital images Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.

Device Class : 2

Duns Number: 437331574

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

PROTOZ - B667PROTOZ1 Catalog Number :

Device Description : ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking di ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriaticagent) with different outline colors.