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CHISON Medical Technologies Co., Ltd.

China · Wuxi Jiangsu · www.chison.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000021605

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

45UDI-DI device records

Class IIa 45

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 5Class III 0

plus 18 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class IIa 3

BRBrazilANVISA

7registered devices

Class II 7

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

5active device licences

Class III 5

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 Union45 raw hits, 0 excluded, 45 confirmed

United States18 registration records, 11 510(k), 0 PMA, 1 excluded

United Kingdom3 confirmed, 0 excluded

Brazil7 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: CHISON Medical Technologies Co., Ltd. · CHISON MEDICAL TECHNOLOGIES CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000021605
EU authorised representative: R Sight B.V.
UK responsible person: SHARE INFO LTD

FDA 510(k) clearances by year

12018

12020

62021 · K202457

12023 · K223570

12024 · K233697

12026 · K253949

FDA listed device types

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1System, Image Processing, Radiological 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06945121409766	CHISON	Class IIa
EU	06945121409926	CHISON	Class IIa
EU	06945121409735	CHISON	Class IIa
EU	06945121409728	CHISON	Class IIa
UK	40761	Digital Color Doppler Palm Ultrasound System	Class IIa
UK	40761	Digital Color Doppler Ultrasound System	Class IIa
UK	40761	Ultrasound Diagnostic System	Class IIa
US	K253949	SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6	2026-05-22
US	K233697	SonoMax Series Digital Color Doppler Ultrasound System	2024-08-09
US	K223570	SonoAir Series Digital Color Doppler Ultrasound System	2023-03-31
BR	81346509087	Sistema de Ultrassom Digital com Doppler Colorido	Class II
BR	81504799085	Sistema de Ultrassom Digital com Doppler Colorido	Class II
BR	81504799170	Sistema de ultrassom Doppler colorido digital	Class II
CA	98242	DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM - Q SERIES	Class III
CA	98499	DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM - ECO SERIES	Class III
CA	98508	DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM - SONO TOUCH SERIES	Class III

CHISON Medical Technologies Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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