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

Transducer, Ultrasonic, Diagnostic (ITX) (8) Cart, Emergency, Cardiopulmonary (Excluding Equipment) (BZN) (1)

Premarket Exempt

No Yes

Clear

SIUI - 06938396494049 Catalog Number :

Device Description : Phased Array Transducer

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SIUI - 06938396494056 Catalog Number :

Device Description : Phased Array Transducer

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SIUI - 06938396494063 Catalog Number :

Device Description : Phased Array Transducer

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SIUI - 06938396494070 Catalog Number :

Device Description : Phased Array Transducer

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SIUI - 06938396495022 Catalog Number :

Device Description : Convex Array Transducer

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SIUI - 06938396495046 Catalog Number :

Device Description : Convex Array Transducer

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SIUI - 06938396495053 Catalog Number :

Device Description : Convex Array Transducer

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SIUI - 06938396495084 Catalog Number :

Device Description : Volume Probe

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SIUI - 06938396497002 Catalog Number :

Device Description : CR Series Trolley, CR Series Cart, used to transport medical ultrasound machines.

Device Class : 1

Duns Number: 654090299

Premarket Exempt : Yes

Product Code : BZN

Prescription Use : No

Device Count : 1

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