EPS BIO TECHNOLOGY CORP.

Address:No. 8, R&D Rd. III,Hsinchu,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)

Premarket Exempt

Clear

EasyMax Blood Glucose Test Strip - 00885017000010 Catalog Number :

Device Description : 50 strips in a vial

Device Class :

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

EasyMax V Self-Monitoring Blood Glucose System - 00885017000058 Catalog Number :

Device Description : one blood glucose meter

Device Class :

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

EasyMax NG Self-Monitoring Blood Glucose System - 00885017000065 Catalog Number :

Device Description : Semi kit: one blood glucose meter

Device Class :

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

EasyMax LTC Self-Monitoring Blood Glucose System - 00885017000102 Catalog Number :

Device Description : Semi kit: one blood glucose meter

Device Class :

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

EasyMax 15 Blood Glucose Test Strip - 00885017000171 Catalog Number :

Device Description : 10 strips in a vial

Device Class : 2

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

FortisCare Blood Glucose Test Strip - 00885017000263 Catalog Number :

Device Description : 25 strips in a vial.

Device Class : 2

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

25 EasyMax FTS Set EN-ES - 00885017000270 Catalog Number :

Device Description : The EASY MAX Glucose Test Strips are intended for the quantitative measurement o The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. The EASY MAX Glucose Test Strips must be used with the EASY MAX Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Device Class : 2

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

25 EasyMax 15 FTS Set EN-ES - 00885017000287 Catalog Number :

Device Description : The EASY MAX 15 Glucose Test Strips are intended for the quantitative measuremen The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.

Device Class : 2

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

FortisCare Self-Monitoring Blood Glucose System - 00885017000300 Catalog Number :

Device Description : 1 blood glucose meter

Device Class : 2

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

FortisCare Blood Glucose Test Strip - 00885017000317 Catalog Number :

Device Description : 50 strips in a vial

Device Class : 2

Duns Number: 658620117

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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