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) (9) Glucose Dehydrogenase, Glucose (LFR) (8) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (4)

Premarket Exempt

Clear

GL GoodLife Blood Glucose Test Strip - 00389154000594 Catalog Number : 3S-01-16003E

Device Description : GL GoodLife Blood Glucose Test Strip(AC-302)

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

GL GoodLife Blood Glucose Monitoring System - 00389154000617 Catalog Number : 3K-01-16003N

Device Description : Only GL GoodLife Blood Glucose Meter. No GCS in package, Economy type

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

GL GoodLife AC-302 Blood Glucose Monitoring System - 00389154000631 Catalog Number : 3K-01-16003R

Device Description : GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type.

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : No

Device Count : 1

GL GoodLife Blood Glucose Meter AC-11 - 00389154000679 Catalog Number : 3K-01-16003S

Device Description : GL GoodLife Blood Glucose Meter (single patient home use)

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, JJX

Prescription Use : No

Device Count : 1

GL GoodLife AC11-Strip(foil) - 00389154000693 Catalog Number : 3L-10-16003F

Device Description : GL GoodLife Blood Glucose Test Strip(Content:50 strips and 50 lancet.)

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW, LFR, JJX

Prescription Use : No

Device Count : 1

metene Enhance Blood Glucose Monitoring System - 00850009854032 Catalog Number : 3K-01-250034

Device Description : metene Enhance P5 Blood Glucose Monitoring System

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

metene Enhance Blood Glucose vial packed test strip - 00850009854049 Catalog Number : 3S-01-250035

Device Description : metene Enhance C4H Blood Glucose vial packed test strip

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GL GoodLife AC-302 Blood Glucose Monitoring System, Economy type(CORP.) - 00857596008008 Catalog Number : 3K-01-16003N

Device Description : GL GoodLife AC-302 Blood Meter(No GCS), Economy type

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) - 00857596008022 Catalog Number : 3K-01-16003R

Device Description : GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type.

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW, JJX, LFR

Prescription Use : No

Device Count : 1

GL GoodLife Blood Glucose Test Strip(CORP.) - 00857596008046 Catalog Number : 3S-01-16003E

Device Description : GL GoodLife Blood Glucose Test Strip(AC-302)

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

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