HMD BIOMEDICAL INC.

Address:No 181 Minsheng St, Xinpu Township,Hsinchu County,TW

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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 Dehydrogenase, Glucose (LFR) (5) Glucose Oxidase, Glucose (CGA) (5) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (4)

Premarket Exempt

Clear

PRECICHEK AutoCode foil packed test strip - 04260236851111 Catalog Number : 3L-10-16003H

Device Description : PRECICHEK AutoCode Blood Glucose ACH foil packed test strip

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW, JJX, LFR

Prescription Use : Yes

Device Count : 1

PRECICHEK AutoCode foil packed test strip - 04260236851142 Catalog Number : 3L-10-16003B

Device Description : PRECICHEK AutoCode Blood Glucose ACH foil packed test strip

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : No

Device Count : 1

PRECICHEK AutoCode vial packed test strip - 04260236851159 Catalog Number : 3S-01-160037

Device Description : PRECICHEK AutoCode Blood Glucose ACH vial packed test strip.

Device Class : 1

Duns Number: 658644174

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : No

Device Count : 1

FIA Salut vial packed test strip(for SS) - 04260236851326 Catalog Number : 3S-01-1400332

Device Description : FIA Salut Blood Glucose KPH vial packed test strip(for SS)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose Test Strip - 04711200720068 Catalog Number : 3S-01-22X034

Device Description : GlucoLeader Enhance GL Blood Glucose Test Strip

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose vial packed test strip - 04711200720334 Catalog Number : 3S-01-140035

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 Monitoring System - 04711200720570 Catalog Number : 3K-01-140039

Device Description : GlucoLeader Enhance GEBH Blood Glucose Monitoring System.

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose Monitoring System - 04711200720617 Catalog Number : 3K-01-140036

Device Description : GlucoLeader Enhance GEBH Blood Glucose Monitoring System

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GoodLife foil packed test strip - 04711200721034 Catalog Number : 3L-10-160032

Device Description : GoodLife Blood Glucose ACH foil packed test strip.

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW, LFR, JJX

Prescription Use : No

Device Count : 1

GlucoLeader Enhance Blood Glucose Test Strip(for AF-SSA) - 04711200721249 Catalog Number : 3S-01-1400333

Device Description : GlucoLeader Enhance GL Blood Glucose Test Strip(for AF-SSA)

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

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