DARIOHEALTH CORP.

Address:18 W. 18th Street,New York,NY,10011,US

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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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (6) Scale, Stand-On, Patient (FRI) (2)

Premarket Exempt

No Yes

Clear

Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System - 00850033352009 Catalog Number :

Device Description : The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital

Device Class :

Duns Number: 116902485

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Dario Smart Scale (Cellular) - Weight Management System - 00850033352023 Catalog Number :

Device Description : The Dario Smart Scale (Cellular) - Weight Management System is intended for meas

Device Class : 1

Duns Number: 116902485

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

Dario Smart Blood Pressure Monitor Gen 2 - 00850033352061 Catalog Number :

Device Description : The Dario blood pressure monitoring system is intended for measuring blood press

Device Class : 2

Duns Number: 116902485

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Dario Blood Pressure Monitoring System (Large cuff) - 00850033352078 Catalog Number :

Device Description : The Dario Blood Pressure Monitoring System is intended to be used to measure the

Device Class : 2

Duns Number: 116902485

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Dario Blood Pressure Monitoring System (M cuff) - 00850033352085 Catalog Number :

Device Description : The Dario Blood Pressure Monitoring System is intended to be used to measure the

Device Class : 2

Duns Number: 116902485

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Dario Smart Scale - 00850033352092 Catalog Number :

Device Description : The Dario Smart Scale will accurately measure the weight of children and adults

Device Class : 1

Duns Number: 116902485

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

Dario Blood Pressure Monitoring System (M cuff) - 00850065006345 Catalog Number :

Device Class : 2

Duns Number: 116902485

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Dario Blood Pressure Monitoring System (Large cuff) - 00850065006437 Catalog Number :

Device Class : 2

Duns Number: 116902485

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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