All Medicus Co.,Ltd.

Address:No.7102-7107,7402,7403,7406, 140, Beolmal-ro,Anyang-si Gyeonggi,KR

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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) (7) Glucose Dehydrogenase, Glucose (LFR) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (3)

Premarket Exempt

Clear

Embrace Pro Control Solution - 08806128340002 Catalog Number :

Device Class : 1

Duns Number: 688022826

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : Yes

Device Count : 1

Embrace Pro Blood Glucose Test Strip - 08806128340019 Catalog Number :

Device Class :

Duns Number: 688022826

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : Yes

Device Count : 25

Embrace Pro Blood Glucose Test Meter - 08806128340064 Catalog Number :

Device Class : 1

Duns Number: 688022826

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : Yes

Device Count : 1

metene Control Solution - 08806128351503 Catalog Number :

Device Class : 2

Duns Number: 688022826

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

metene Blood Glucose Test Strip - 08806128351534 Catalog Number :

Device Class :

Duns Number: 688022826

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 50

metene Blood Glucose Test Meter - 08806128351565 Catalog Number :

Device Class : 2

Duns Number: 688022826

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

metene Blood Glucose Monitoring System - 08806128351589 Catalog Number :

Device Class : 2

Duns Number: 688022826

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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