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Wuxi Hisky Medical Technologies Co., Ltd

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000022547Unified social credit code 91320214559326175D

This company holds 11 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

11China registrations

Class I 1Class II 5Class III 5

as of 2026-09-04

EUEuropean UnionEUDAMED

56UDI-DI device records

Class IIa 56

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 5 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union56 raw hits, 0 excluded, 56 confirmed

United States5 registration records, 5 510(k), 0 PMA

China11 certificates (Class III 5 / II 5 / I 1), as of 2026-09-04

United Kingdom1 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000022547
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91320214559326175D
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2010-07-30
Registered capital: CNY 15,203,749
Paid-in capital: CNY 15,203,749
Legal form: Limited liability company (HK/Macao/Taiwan invested, not wholly owned, not wholly owned)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-01-07
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle enterpriseRecognised enterprise technology centre

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263071460	定量剪切波超声肝脏测量仪	Class III
CN	国械注准20243070714	定量剪切波超声肝脏测量仪	Class III
CN	国械注准20243070249	定量剪切波超声肝脏测量仪	Class III
CN	国械注准20233072014	定量剪切波超声肝脏测量仪	Class III
EU	06971679949508	—	Class IIa
EU	06971679949492	—	Class IIa
EU	06971679949140	—	Class IIa
EU	06971679949461	—	Class IIa
UK	58710	Shear Wave Quantificational Ultrasound Diagnostic System	Class IIa
US	K250026	Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)	2025-10-01
US	K243711	Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);	2025-07-24
US	K243880	Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)	2025-06-17
BR	80102512289	Sistema Diagnóstico por Ultrassom de Quantificação de Ondas de Cisalha	Class II

Wuxi Hisky Medical Technologies Co., Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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