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) (1)

Premarket Exempt

Clear

RIGHTEST GT333 Control Solution - 00883489001924 Catalog Number :

Device Class : 1

Duns Number: 658637244

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

RIGHTEST - 00883489001993 Catalog Number :

Device Description : 1 meter - 008834890019861 lancing device - 008834890020131 control solution -008 1 meter - 008834890019861 lancing device - 008834890020131 control solution -00883489002020

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

RIGHTEST - 00883489002037 Catalog Number :

Device Description : 25 pcs strips(80883489002033) per vial, 2 vials(00883489002037) per box

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

ODM - 00883489002372 Catalog Number : 99GM280DR1

Device Description : 1 meter - 00883489002372

Device Class : 2

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ODM - 00883489002396 Catalog Number : 99GM282DR1

Device Description : 1 meter - 00883489002396

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ODM - 00883489002419 Catalog Number : 99GS280D51

Device Description : 25 strips - 80883489002415

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

Rightest - 00883489310293 Catalog Number :

Device Class : 2

Duns Number: 658637244

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GE - 00883489310309 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 25

GE - 10883489084849 Catalog Number : 99GM555CZ1

Device Description : The combination products includes 2 boxes(00883489001207) of meters(008834890011 The combination products includes 2 boxes(00883489001207) of meters(00883489001191) and 8 boxes(00883489001245) of strips(00883489001238)

Device Class : 2

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

GE - 10883489310436 Catalog Number :

Device Description : one box contained 2 meter kitbox and 8 50pcs-strip box.

Device Class : 2

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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