Xuzhou Kaixin Electronic Instrument Co., Ltd.

Manufacturer and brand owner in Xuzhou, Jiangsu, China. 2 device types, 1 product catalogued, 1 clearance.

Registry build 21.09.26

Xuzhou Kaixin Electronic Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Transducer, Ultrasonic, Diagnostic, System, Imaging, Pulsed Echo, Ultrasonic. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.

2device types registered with the FDA
1product
1510(k) clearance

Registration

FDA registration record for Xuzhou Kaixin Electronic Instrument Co., Ltd.
Registered name XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO., LTD.
Status Registered
Registration expires 2026
Registration number 3012387143
FEI number 3012387143
DUNS 545276982
Establishment type Manufacturer, Exporter

Location

Address of Xuzhou Kaixin Electronic Instrument Co., Ltd.
City Xuzhou
Province Jiangsu
Address Kaixin Mansion, C-01, Economic Development Zone, Xuzhou, Jiangsu,China.
Postal code 221004
Country China

What It Makes

Device types Xuzhou Kaixin Electronic Instrument Co., Ltd. is registered to make
Device type Class Listed since Chinese makers
System, Imaging, Pulsed Echo, Ultrasonic Class 2 2023 37
Transducer, Ultrasonic, Diagnostic Class 2 2023 44

Own-Brand Listings

Devices catalogued by Xuzhou Kaixin Electronic Instrument Co., Ltd.
Product Code Catalogue numbers
Bladder Scanner IYO 1

Clearances

510(k) clearances naming Xuzhou Kaixin Electronic Instrument Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K223448 2023-07-07 IYO Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Xuzhou Kaixin Electronic Instrument Co., Ltd.
Founded 1997
Employees 100-200
Main products Human ultrasound scanners, Veterinary ultrasound scanners, Color Doppler ultrasound, Ophthalmic ultrasound equipment, Bladder scanners
Certifications CE, RoHS, ISO13485, ISO9001, EN ISO 13485, TUV
Export markets More than 160 countries worldwide

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer