Edan Instruments, Inc.

Address:#15 Jinhui Road, Jinsha Community,Shenzhen Guangdong,CN

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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

Monitor, Blood-Flow, Ultrasonic (HEP) (6) Monitor, Ultrasonic, Fetal (KNG) (6) Electrocardiograph (DPS) (2) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1) System, Monitoring, Perinatal (HGM) (1)

Premarket Exempt

No Yes

Clear

Ultrasonic Pocket Doppler - 06944413800120 Catalog Number :

Device Class :

Duns Number: 529173163

Premarket Exempt : No

Product Code : KNG, HEP

Prescription Use : Yes

Device Count : 1

Ultrasonic Pocket Doppler - 06944413800137 Catalog Number :

Device Class :

Duns Number: 529173163

Premarket Exempt : No

Product Code : KNG, HEP

Prescription Use : Yes

Device Count : 1

Ultrasonic Pocket Doppler - 06944413800144 Catalog Number :

Device Class :

Duns Number: 529173163

Premarket Exempt : No

Product Code : KNG, HEP

Prescription Use : Yes

Device Count : 1

Ultrasonic Pocket Doppler - 06944413800151 Catalog Number :

Device Class :

Duns Number: 529173163

Premarket Exempt : No

Product Code : KNG, HEP

Prescription Use : Yes

Device Count : 1

Ultrasonic Pocket Doppler - 06944413800168 Catalog Number :

Device Class :

Duns Number: 529173163

Premarket Exempt : No

Product Code : KNG, HEP

Prescription Use : Yes

Device Count : 1

Ultrasonic Pocket Doppler - 06944413800175 Catalog Number :

Device Class :

Duns Number: 529173163

Premarket Exempt : No

Product Code : KNG, HEP

Prescription Use : Yes

Device Count : 1

Central Monitoring System - 06944413800229 Catalog Number :

Device Class : 2

Duns Number: 529173163

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Central Monitoring System - 06944413800236 Catalog Number :

Device Class : 2

Duns Number: 529173163

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Electrocardiograph - 06944413800298 Catalog Number :

Device Class : 2

Duns Number: 529173163

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Electrocardiograph - 06944413800304 Catalog Number :

Device Class : 2

Duns Number: 529173163

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

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