HYGIEIA, INC.

HYGIEIA, INC.

Address:28803 8 Mile Rd,Livonia,MI,48152,US

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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

Calculator, Drug Dose (NDC) (2)

Premarket Exempt

No

Clear

d-Nav® - 00860001044201 Catalog Number :

Device Description : Hygieia d-Nav System Phone App - Apple iOS Operating System

Device Class : 2

Duns Number: 073601434

Premarket Exempt : No

Product Code : NDC

Prescription Use : Yes

Device Count : 1

d-Nav® - 00860001044218 Catalog Number :

Device Description : Hygieia d-Nav System Phone App - Android Operating System

Device Class : 2

Duns Number: 073601434

Premarket Exempt : No

Product Code : NDC

Prescription Use : Yes

Device Count : 1

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