BIONIME CORPORATION

Address:NO. 100, Sec. 2, Daqing St., South Dist.,Taichung City,TW

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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, Test, Blood Glucose, Over The Counter (NBW) (10) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2)

Premarket Exempt

Clear

GE - 00883489001696 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

GE - 00883489001719 Catalog Number :

Device Description : meter

Device Class : 2

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GE - 00883489001726 Catalog Number :

Device Description : 1 meter -008834890017191 vial of 10 pcs strip -008834890017571 lancing device - 1 meter -008834890017191 vial of 10 pcs strip -008834890017571 lancing device -008834890017711 control solution -008834890017881 pack of 10 pcs lancet -00883489001764

Device Class : 2

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GE - 00883489001733 Catalog Number :

Device Description : One box with 2 vials strip

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

GE - 00883489001795 Catalog Number :

Device Description : GE333 control solution(Normal Level)

Device Class : 1

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, JJX

Prescription Use : No

Device Count : 1

GE - 00883489001818 Catalog Number :

Device Description : GE333 control solution (High level)

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : JJX, NBW

Prescription Use : No

Device Count : 1

RIGHTEST GT333 Blood Glucose Monitoring System - 00883489001849 Catalog Number :

Device Class : 2

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

RIGHTEST GT333 Blood Glucose Test Strip - 00883489001863 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

RIGHTEST GT333 Blood Glucose Test Strip - 00883489001887 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

RIGHTEST GT333 Blood Glucose Test Strip - 00883489001900 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

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