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EXACT IMAGING, INC.

Canada · Markham

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 5Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

pendingnot queried

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, 9 excluded

Brazil1 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: EXACT IMAGING, INC. · EXACT IMAGING INC.

FDA 510(k) clearances by year

12016 · K162972

12018 · K180636

22019 · K192303

FDA listed device types

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192303	ExactVu High Resolution Micro-Ultrasound System	2019-10-01
US	K190995	ExactVu High Resolution Micro-Ultrasound System	2019-05-10
US	K180636	ExactVu High Resolution Micro-Ultrasound System	2018-04-30
BR	81639919001	Sistema de Micro-Ultrassom de Alta Resolução ExactVu	Class II

EXACT IMAGING, INC.

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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