ARKRAY USA, INC.

Address:Yousuien-nai,Kamigyo-ku Kyoto,JP

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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

GLUCOSE OXIDASE, GLUCOSE (CGA) (2) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (2)

Premarket Exempt

No Yes

Clear

GLUCOCARD® Vital™ Blood Glucose Monitoring System - 30015482761883 Catalog Number :

Device Description : DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GLUCOCARD® Vital™ Blood Glucose Monitoring System - 30015482761999 Catalog Number :

Device Description : Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU