Bionet CO,LTD

Bionet CO,LTD

Address:401, 34, LS-ro 91beon-gil, Dongan-gu,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

Electrocardiograph (DPS) (4) System, Monitoring, Perinatal (HGM) (2) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (1) Spirometer, Diagnostic (BZG) (1)

Premarket Exempt

No

Clear

CardioXP - 08809276940285 Catalog Number :

Device Description : ELECTROCARDIOGRAPH

Device Class : 2

Duns Number: 689708212

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

CardioCare2000 - 08809276943538 Catalog Number :

Device Description : System, ecg analysis

Device Class : 2

Duns Number: 689708212

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

CardioTouch3000 - 08809276943545 Catalog Number :

Device Description : System, ecg analysis

Device Class : 2

Duns Number: 689708212

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

Cardio7 - 08809276943552 Catalog Number :

Device Description : ELECTROCARDIOGRAPH

Device Class : 2

Duns Number: 689708212

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

FC700 - 08809276943590 Catalog Number :

Device Description : SYSTEM, MONITORING, PERINATAL

Device Class : 2

Duns Number: 689708212

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

FC1400 - 08809276943606 Catalog Number :

Device Description : SYSTEM, MONITORING, PERINATAL

Device Class : 2

Duns Number: 689708212

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

BM3/BM3 Plus - 08809276943644 Catalog Number :

Device Description : MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Device Class : 2

Duns Number: 689708212

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Spiro Handle - 08809276943729 Catalog Number :

Device Description : SPIROMETER, DIAGNOSTIC

Device Class : 2

Duns Number: 689708212

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

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