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) (9) Glucose Oxidase, Glucose (CGA) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (3) Calculator/Data Processing Module, For Clinical Use (JQP) (1)

Premarket Exempt

Clear

GE - 00883489001436 Catalog Number :

Device Class : 1

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, JJX

Prescription Use : No

Device Count : 1

GE - 00883489001443 Catalog Number :

Device Class : 1

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, JJX

Prescription Use : No

Device Count : 1

Rightest - 00883489001450 Catalog Number :

Device Class : 1

Duns Number: 658637244

Premarket Exempt : No

Product Code : JQP, NBW

Prescription Use : No

Device Count : 1

Rightest - 00883489001498 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 10

ODM - 00883489001504 Catalog Number : 99GM291I01

Device Description : The combination products includes 1 pce of lancing device_GD500(00883489001566), The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573).

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

ODM - 00883489001542 Catalog Number : 99GS291I51

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 25

Rightest - 00883489001603 Catalog Number :

Device Class : 1

Duns Number: 658637244

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

GE - 00883489001634 Catalog Number :

Device Description : meter

Device Class : 2

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GE - 00883489001658 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

GE - 00883489001672 Catalog Number :

Device Description : strip vial

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

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