OSANG HEALTHCARE Co., Ltd.

Address:132, Anyangcheondong-ro,ANYANG 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

Glucose Oxidase, Glucose (CGA) (3) System, Test, Blood Glucose, Over The Counter (NBW) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2)

Premarket Exempt

Clear

Element™ Meter - 08809115908452 Catalog Number :

Device Description : Blood Glucose Monitoring System

Device Class :

Duns Number: 688195374

Premarket Exempt : No

Product Code : JJX, NBW, CGA

Prescription Use : No

Device Count : 1

Element™Plus Test Strips - 08809115908957 Catalog Number :

Device Description : Blood Glucose Monitoring System

Device Class :

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

Element™Plus Meter - 08809115908971 Catalog Number :

Device Description : Blood Glucose Monitoring System

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : CGA, NBW, JJX

Prescription Use : No

Device Count : 1

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