HMD BIOMEDICAL INC.

Address:No 181 Minsheng St, Xinpu Township,Hsinchu County,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) (4) Glucose Oxidase, Glucose (CGA) (2)

Premarket Exempt

Clear

GlucoLeader Enhance Blood Glucose vial packed test strip - 04711200722840 Catalog Number : 3S-01-14003Y

Device Description : GlucoLeader Enhance GL Blood Glucose vial packed test strip

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose Test Strip - 04711200722864 Catalog Number :

Device Description : GlucoLeader Enhance GL Blood Glucose Test Strip

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Renpho Blood Glucose Monitoring System - 04711200722888 Catalog Number :

Device Description : Renpho Blood Glucose Monitoring System

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Renpho Blood Glucose vial packed test strip - 04711200722895 Catalog Number :

Device Description : Renpho Blood Glucose vial packed test strip

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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