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) (10) Glucose Oxidase, Glucose (CGA) (3) Glucose Dehydrogenase, Glucose (LFR) (1)

Premarket Exempt

Clear

GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ) - 04711200721720 Catalog Number : 3S-01-14010A

Device Description : GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose vial packed test strip - 04711200721744 Catalog Number : 3S-01-1400336

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 foil packed test strip - 04711200721843 Catalog Number : 3L-10-14003T

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

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GL GoodLife - 04711200721850 Catalog Number : 3K-01-16003G

Device Description : The GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : Yes

Device Count : 1

GlucoLeader Enhance Blood Glucose Test Strip(for PTA) - 04711200721898 Catalog Number : 3L-10-120032

Device Description : GlucoLeader Enhance GL Blood Glucose Test Strip(for PTA)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ) - 04711200722246 Catalog Number : 3K-01-140108

Device Description : GlucoLeader Enhance P5 Blood Glucose Monitoring System (BR/IQ)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose Monitoring System(BR/BMT) - 04711200722284 Catalog Number : 3K-01-14010C

Device Description : GlucoLeader Enhance P5 Blood Glucose Monitoring System (BR/BMT)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT) - 04711200722291 Catalog Number : 3S-01-14010J

Device Description : GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/BMT)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose Test Strip(BR/VM) - 04711200722444 Catalog Number : 3S-01-14010B

Device Description : GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/VM)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GlucoseLeader Enhance Blood Glucose Monitoring System(BR/VM) - 04711200722451 Catalog Number : 3K-01-14010B

Device Description : GlucoseLeader Enhance P5 Blood Glucose Monitoring System(BR/VM)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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