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

Premarket Exempt

Clear

Rosie SmartMeter NFC Professional - 00868665000045 Catalog Number : 3K-01-16003K

Device Description : Rosie SmartMeter NFC Professional Blood Glucose Meter

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : Yes

Device Count : 1

Rosie SmartMeter Professional Strip - 00868665000052 Catalog Number : 3L-10-16003E

Device Description : Rosie SmartMeter Professional Strip-Foil

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW

Prescription Use : Yes

Device Count : 1

Rosie SmartMeter Glucose Control Solutions - 00868665000069 Catalog Number : 3C-01-160033

Device Description : Rosie SmartMeter glucose control solution

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : JJX, NBW, LFR

Prescription Use : Yes

Device Count : 1

Rosie SmartMeter Test Strips 50ct(vial) - 00868665000076 Catalog Number : 3S-01-16003A

Device Description : Rosie SmartMeter Blood Glucose GDH-FAD Test Strips

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : Yes

Device Count : 1

FIA Salut CS06 - 04260236850244 Catalog Number : 3K-01-1400316

Device Description : FIA Salut CS06 Blood Glucose Monitoring System.

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

PRECICHEK AutoCode foil packed test strip - 04260236850329 Catalog Number : 3L-10-160031

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

FIA Salut foil packed test strip - 04260236850367 Catalog Number : 3L-10-140033

Device Description : FIA Salut Blood Glucose KPH foil packed test strip

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

PRECICHEK AutoCode vial packed test Strip - 04260236850411 Catalog Number : 3S-01-160032

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

Device Class :

Duns Number: 658644174

Premarket Exempt : No

Product Code : NBW, JJX, LFR

Prescription Use : Yes

Device Count : 1

FIA Salut foil packed test strip(for SS) - 04260236850459 Catalog Number : 3L-10-14003A

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

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

FIA Salut vial packed test strip - 04260236850466 Catalog Number : 3S-01-1400335

Device Description : FIA Salut Blood Glucose KPH vial packed test strip.

Device Class : 2

Duns Number: 658644174

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

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