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QISDA CORPORATION

Taiwan · Taoyuan

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel, 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

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 6 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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.

United States6 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: QISDA CORPORATION

FDA 510(k) clearances by year

12014 · K132690

12017 · K172056

12018 · K181313

12019 · K192254

FDA listed device types

System, Imaging, Pulsed Doppler, Ultrasonic 1Laparoscope, General & Plastic Surgery 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192254	InnoSight Diagnostic Ultrasound System	2019-09-18
US	K181313	BenQ Diagnostic Ultrasound System	2018-08-27
US	K172056	InnoSight Diagnostic Ultrasound System	2017-12-13
BR	10216710361	Sistema de Ultrassom Innosight	Class II

QISDA CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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