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Shenzhen Wisonic Medical Technology Co., Ltd.

China · Shenzhen Guangdong · www.wisonic.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000005656

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Israel, Russia — 9 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

102UDI-DI device records

Class IIa 100Class IIb 2

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 7 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class IIa 2Class IIb 1

BRBrazilANVISA

2registered devices

Class II 2

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

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

10device registrations

CLASS B 10

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

IIa 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 Union102 raw hits, 0 excluded, 102 confirmed

United States7 registration records, 7 510(k), 0 PMA

United Kingdom3 confirmed, 0 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000005656
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Wellkang Ltd

FDA 510(k) clearances by year

32018 · K182715

12020 · K191347

22021 · K211886

12023 · K230066

FDA listed device types

Biopsy Needle Guide Kit 1System, Imaging, Pulsed Doppler, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06971355420031	Ultrasonic Diagnostic System	Class IIa
EU	06971355420437	Ultrasonic Diagnostic System	Class IIa
EU	06971355420420	Ultrasonic Diagnostic System	Class IIa
EU	06971355420413	Ultrasonic Diagnostic System	Class IIa
UK	33586	Patient Monitor	Class IIb
UK	40761	Ultrasonic Diagnostic System	Class IIa
UK	40761	Ultrasonic Diagnostic System	Class IIa
US	K230066	Carnation series Diagnostic Ultrasound System	2023-09-15
US	K211886	Clivia series Diagnostic Ultrasound System	2021-12-02
US	K210154	Labat series Diagnostic Ultrasound System	2021-07-30
BR	81464759023	Sistemas de Ultrassom Diagnóstico	Class II
BR	81464759001	Sistemas de Ultrassom Diagnóstico	Class II

Shenzhen Wisonic Medical Technology 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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