HomeIsraelViasonix Ltd.

Viasonix Ltd.

Israel · Ra'Anana · www.viasonix.com
✓ Record-verifiedregistrations found in 12 marketsEU SRN IL-MF-000021015

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 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
32UDI-DI device records
Class I 7Class IIa 25
USUnited StatesFDA openFDA
5listed device types
Class I 0Class II 5Class III 0
plus 6 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 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
2 including historic records
TWTaiwanTFDA
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
3registrations
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.

European Union32 raw hits, 0 excluded, 32 confirmed
United States6 registration records, 6 510(k), 0 PMA
United Kingdom1 confirmed, 0 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: Viasonix Ltd. · VIASONIX LTD. · Viasonix Ltd

Regulatory identity

EU manufacturer SRN
IL-MF-000021015
EU authorised representative
Arazy Group GmbH
UK responsible person
Larwood Associates Limited

Company information

Country
Israel
City
Ra'Anana
Website
www.viasonix.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentNeurology & neurosurgery

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
VIASONIX LTD
Company number
514218742
Registration status
Active
Incorporated
2009-01-04

Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12011 · K111416
12017 · K170859
22019 · K192607
12021 · K202742
12024 · K242662

FDA listed device types

Transducer, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1Diagnostic Ultrasonic Transducer, Robotic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Massager, Powered Inflatable Tube 1

Registration details (sample)

MarketIdentifierNameClass / date
EU07290016880175PPG Disk sensors (Green, Red)Class IIa
EU07290016880441PPG Detachable Clip sensorsClass IIa
EU07290016880076Basler 10MHz probe Class IIa
EU07290016880069Basler 8MHz probe Class IIa
UK61236Dolphin/4DClass IIa
USK242662Falcon/Xpress (Falcon/Xpress)2024-12-18
USK202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory2021-01-25
USK192607LiteWalk2019-12-19
BR80701360002Doppler CranianoClass II
BR80701360001Falcon - Sistema de Diagnóstico Vascular PeriféricoClass II

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