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ACIST MEDICAL SYSTEMS, INC.

USA · Eden Prairie

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

9listed device types

Class I 0Class II 9Class III 0

plus 24 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

10 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

15active ARTG entries

Class I 2IIa 8IIb 5

HKHong KongMDACS

9valid listings

Class II 5Class III 2Class IV 2

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 3 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 States24 registration records, 24 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: ACIST MEDICAL SYSTEMS, INC. · ACIST MEDICAL SYSTEMS INC. · ACIST MEDICAL SYSTEMS, INC

FDA 510(k) clearances by year

21999

22000

12001

22002

12003

12004

12005

12010

12014

22017

12018

32019

22020

12024

32026

FDA listed device types

showing 8 of 9

Catheter, Pressure Monitoring, Cardiac 1System, Imaging, Pulsed Echo, Ultrasonic 1Amplifier And Signal Conditioner, Transducer Signal 1Plethysmograph, Impedance 1System, X-Ray, Tomography, Computed 1Injector And Syringe, Angiographic 1Injector, Contrast Medium, Automatic 1Catheter, Ultrasound, Intravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262115	VueJect® Ultrasound Enhancing Agent Delivery System	2026-08-03
US	K252638	VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)	2026-05-13
US	K252653	ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable	2026-05-13
BR	80580329001	ACIST AT-P	Class II
BR	80580329002	ACESSÓRIOS PARA INJETORAS ACIST	Class II
BR	80580329003	ACIST BT2000	Class II
CA	64310	EMPOWERCTA CONNECTING TUBE	Class II
CA	67782	EMPOWER TRANSFER SET	Class II