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Spectrum Dynamics Medical, Ltd.

Israel · Caesarea

✓ Record-verifiedregistrations found in 8 markets

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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

15listed device types

Class I 2Class II 13Class III 0

plus 53 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 1Class III 2

29 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 2IIb 1

HKHong KongMDACS

1valid listings

Class II 1

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 States53 registration records, 35 510(k), 0 PMA, 36 excluded

Brazil3 confirmed, 5 excluded

Canada3 confirmed, 5 excluded

Manufacturer names merged into this page: SPECTRUM MEDICAL SRL · SPECTRUM MEDICAL LTD · Spectrum Dynamics Medical Ltd. · Spectrum Dynamics Medical Inc. · SPECTRUM DYNAMICS MEDICAL LTD. · SPECTRUM MEDICAL LTD.

FDA 510(k) clearances by year

22006

32007

12009

22011

22016

12017

62018

22019

32020

22021

12022

12023

22024

42025

32026

FDA listed device types

showing 8 of 15

Heat-Exchanger, Cardiopulmonary Bypass 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 1Automated Radiological Image Processing Software 1Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1System, Image Processing, Radiological 1System, Tomography, Computed, Emission 1Console, Heart-Lung Machine, Cardiopulmonary Bypass 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252541	Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W	2026-03-12
US	K240934	Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);	2026-03-12
US	K254001	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	2026-01-13
BR	80012590219	Sistema de Imagens Cardíacas D-SPECT	Class II
BR	80012590228	CORRIDOR 4DM	Class II
BR	80012590229	CARDIAC SUIT	Class II
CA	77605	SYSTEM M MONITORING SYSTEM	Class III
CA	88805	M4 ONLINE MONITOR SYSTEM	Class III
CA	110875	QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP WITH INTEGRATED HEAT EXCHANGER	Class II

Spectrum Dynamics Medical, Ltd.

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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