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

Glucose Dehydrogenase, Glucose (LFR) (10) System, Test, Blood Glucose, Over The Counter (NBW) (10) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (8)

Premarket Exempt

Clear

GL GoodLife Blood Glucose Test Strip AC (50ct in foil) - 00389154000075 Catalog Number : 3K-01-16003C

Device Description : GoodLife AC Blood Glucose Test Strips

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : Yes

Device Count : 1

GL GoodLife - 00389154000198 Catalog Number : 3K-01-16003C

Device Description : GL GoodLife AC-300 Blood Glucose Monitoring System

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) - 00389154000204 Catalog Number : 3L-10-16003A

Device Description : GL GoodLife Blood Glucose Test Strip(Foil)

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : Yes

Device Count : 1

GL GoodLife Blood Glucose Test Strip-Foil For Cloudia - 00389154000266 Catalog Number : 3L-10-810037

Device Description : GL GoodLife Blood Glucose Test Strip-Foil For Cloudia

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : No

Device Count : 1

GL GoodLife - 00389154000372 Catalog Number : 3K-01-810037

Device Description : GL GoodLife Blood Glucose Monitoring System(Cloudia)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : No

Device Count : 1

Rosie SmartMeter - 00389154000389 Catalog Number : 3K-01-16003H

Device Description : Rosie SmartMeter Blood Glucose Monitoring System

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : Yes

Device Count : 1

GL GoodLife Glucose Control Solution(Level 1) - 00389154000440 Catalog Number : 3C-01-810032

Device Description : GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glu

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : No

Device Count : 1

Rosie SmartMeter - 00389154000501 Catalog Number : delete

Device Description : Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMe

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : Yes

Device Count : 1

GL GoodLife Glucose Control Solutions - 00389154000549 Catalog Number : 3C-01-160032

Device Description : GL GoodLife Glucose Control Solution

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : No

Device Count : 1

GL GoodLife AC300 Test Strip-Vial - 00389154000570 Catalog Number : 3S-01-16003C

Device Description : GL GoodLife AC300 Blood Glucose Test Strip

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : Yes

Device Count : 1

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