NIDEK TECHNOLOGIES SRL

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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) Perimeter, Automatic, Ac-Powered (HPT) (1)

Premarket Exempt

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MP-1S - B310MP1S0 Catalog Number :

Device Description : The MP-1S MICRO PERIMETER is indicated for use as:·Color retinography·Fixation e The MP-1S MICRO PERIMETER is indicated for use as:·Color retinography·Fixation examiner·Fundus-related microperimetry·Visual rehabilitation

Device Class : 1

Duns Number: 436748037

Premarket Exempt : No

Product Code : HKI, HPT

Prescription Use : Yes

Device Count : 1

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