Wuxi Hisky Medical Technologies Co., Ltd.

Manufacturer and brand owner in Wuxi, Jiangsu, China. 4 device types, 5 products catalogued, 5 clearances.

Registry build 21.09.26

Wuxi Hisky Medical Technologies Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Confocal Optical Imaging, Transducer, Ultrasonic, Diagnostic and 2 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.

4device types registered with the FDA
5products catalogued under its own name
5510(k) clearances

Registration

FDA registration record for Wuxi Hisky Medical Technologies Co., Ltd.
Registered name WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
Status Registered
Registration expires 2026
Registration number 3016493665
FEI number 3016493665
DUNS 544348534
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Wuxi Hisky Medical Technologies Co., Ltd.
Chinese legal name 无锡海斯凯尔医学技术有限公司
Unified social credit code 91320214559326175D
Source NMPA UDI database

Location

Address of Wuxi Hisky Medical Technologies Co., Ltd.
City Wuxi
Province Jiangsu
Address Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi,
Postal code 214135
Country China

What It Makes

Device types Wuxi Hisky Medical Technologies Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Confocal Optical Imaging Class 2 Confocal Microprobe Imaging System 2025 3
System, Imaging, Pulsed Doppler, Ultrasonic Class 2 iLivTouch 2020 22
System, Imaging, Pulsed Echo, Ultrasonic Class 2 iLivTouch 2020 37
Transducer, Ultrasonic, Diagnostic Class 2 iLivTouch 2020 44

Own-Brand Listings

Devices catalogued by Wuxi Hisky Medical Technologies Co., Ltd.
Product Code Catalogue numbers
Confocal Microprobe Imaging System OWN 16
Shear Wave Quantificational Ultrasound Diagnostic System IYN 12
Shear Wave Quantificational Ultrasound Diagnostic System IYO 4
Imaging Probe ITX 1
Fibrosis Scanning Probe ITX 1

Clearances

510(k) clearances naming Wuxi Hisky Medical Technologies Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K250026 2025-10-01 IYN Traditional This company
K243711 2025-07-24 OWN Traditional This company
K243880 2025-06-17 IYO Traditional This company
K200136 2020-03-17 IYO Traditional This company
K173595 2018-06-22 IYO Traditional This company

From the Company

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

Information published by Wuxi Hisky Medical Technologies Co., Ltd.
Founded 2010
Employees 51-200
Main products iLivTouch non-invasive liver detection system
Certifications FDA approval, CE certification
Export markets United States, European Union

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
Wuxi Lyusmile IMP AND EXP Co., Ltd. 66
GE Medical Systems (China) Co., Ltd. 57
Gcmedica Enterprise Ltd.(Wuxi) 55
Emsrun Group 34
PRO-MED (Wuxi)IMP.& Exp.co., Ltd. 24
Wuxi Zontai Int’l Corporation Ltd. 22
Bioteke Corporation (Wuxi) Co., Ltd. 21
Inmed (Wuxi) Medical Device Co., Ltd. 17
Orthguide Medical Technology (Jiangsu) Co., Ltd. 17
Innovative Material & Devices, Inc. 13
Wuxi TP Orthodontics Material Co., Ltd. 9
Jiangsu Haize Medical Scientific Development Co., Ltd. 9
Visuscience Meditech Co., Ltd. 9
Wuxi Yushou Medical Appliances Co., Ltd. 8
Lincotek (Wuxi) Co., Ltd. 7
Linc Medipharm Limited 6
Wuxi Jiajian Medical Instrument Co., Ltd. 6
Wuxi EA Medical Instruments Technologies Limited 6
Jiangsu Xinbei Electrical Appliances Co., Ltd. 6
Wuxi Wemade Healthcare Products Co., Ltd. 6
Aupcon Medical Technology (Wuxi) Co., Ltd. 5
Wuxi Xindi Medical Technology Co., Ltd. 5
Goldcredit International Trading Co., Ltd. 5
Chison Medical Technologies Co., Ltd. 5
Wuxi Weigher Factory Co., Ltd. 4
Wuxi Kaishun Medical Device Manufacturing Co., Ltd. 4
Wuxi FUN Gloves Co., Ltd. 3
Jiangsu Fulangte Medical Treatment Technology Co., Ltd. 3
Wuxi Phanpy Baby Products Co., Ltd. 3
Matrixed Reality Technology Co., Ltd. 3
Wuxi Wiseu IMP&EXP Co., Ltd. 3
Wuxi Biohermes BIO & Medical Technology Co., Ltd. 3
JHQ NEW Material Technology Co., Ltd. 3
Farstar (Wuxi) Medical Equipment Co., Ltd. 2
Wuxi Nest Biotechnology Co., Ltd. 2
Siemens X-RAY Vacuum Technology Ltd. 2
Biox Instruments Co Ltd 2
Broad Origin Inc. 2
Wuxi Sunmaxx Technology Co., Ltd. 2
Wuxi Medical Instrument Factory Co., Ltd. 1
Cmeos Medical SCI & Tech (Wuxi) Co., Ltd. 1
Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. 1
Wuxi Vision PRO Ltd 1
Pulnovo Medical (Wuxi) Co., Ltd. 1
Olemy Laser Technology Ltd 1
Varex Imaging Equipment (China) Co., Ltd. 1
Gaush Neotech Ltd. 1
Wuxi Guochen Medical Technology Co., Ltd. 1
Gaofeng Medical Equipment (Wuxi) Co., Ltd. 1
Jiangsu Rayer Medical Technology Co., Ltd. 1
BM Medical Technology Co., Ltd. 1
Wuxi Allied Technologies, Inc. 1

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