PHILOSYS Co., Ltd

Address:28-5, Gwangwol-gil, Okgu-eup,Gunsan-si Jeonbuk,KR

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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) (10) System, Test, Blood Glucose, Over The Counter (NBW) (10)

Premarket Exempt

Clear

Gmate® mini Blood Glucose Monitoring System - 08809301160015 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® STEP Blood Glucose Monitoring System - 08809301160022 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® Origin Blood Glucose Monitoring System - 08809301160077 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® VOICE Blood Glucose Monitoring System - 08809301160084 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® mini Blood Glucose Monitoring System - 08809301160114 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® STEP Blood Glucose Monitoring System - 08809301160121 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® VOICE Blood Glucose Monitoring System - 08809301160138 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® Origin Blood Glucose Monitoring System - 08809301160145 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® mini Blood Glucose Monitoring System - 08809301160152 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Gmate® STEP Blood Glucose Monitoring System - 08809301160169 Catalog Number :

Device Class : 2

Duns Number: 690184887

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

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