Shantou Institute of Ultrasonic Instruments Co., Ltd.

Address:77 JINSHA RD.,SHANTOU 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

System, X-Ray, Mobile (IZL) (7) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1)

Premarket Exempt

No Yes

Clear

SIUI - 06938396466008 Catalog Number :

Device Description : Diagnostic Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

SIUI - 06938396477004 Catalog Number :

Device Description : Digital Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

SIUI - 06938396477011 Catalog Number :

Device Description : Digital Color Doppler Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYO, IYN

Prescription Use : Yes

Device Count : 1

SIUI - 06938396480042 Catalog Number :

Device Description : Portable X-ray Unit

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SIUI - 06938396480059 Catalog Number :

Device Description : Portable X-ray Unit

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SIUI - 06938396481001 Catalog Number :

Device Description : Portable X-ray Unit

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SIUI - 06938396481018 Catalog Number :

Device Description : Portable X-ray Unit

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SIUI - 06938396482107 Catalog Number :

Device Description : Portable X-ray Unit

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SIUI - 06938396482114 Catalog Number :

Device Description : Portable X-ray Unit

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SIUI - 06938396482305 Catalog Number :

Device Description : Portable X-ray Unit

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

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