Siui

FDA UDI

Class II (US FDA UDI)

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Trade Name: SIUI FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: Diagnostic Ultrasound Imaging System FDA UDI
Model / Reference: CTS-3300 FDA UDI
Description: Diagnostic Ultrasound Imaging System FDA UDI

Identifiers

Primary DI / UDI-DI: 06938396433017 FDA UDI
510(k) Number: K061488 FDA UDI
FDA Product Code: IYO FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: General-purpose ultrasound imaging system

Siui by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd.

Sources (1)

FDA UDI 27c7ff90-6b5e-4e24-aea7-5523c13f8e47 34 fields · synced May 30, 2026