# Viasonix Ltd

> Medical device manufacturer record on deviCERTS, compiled from public registries. Viasonix Ltd is a medical device manufacturer based in Israel, with 44 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/viasonix-ltd>
- Country: Israel (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED
- EUDAMED SRN: IL-MF-000021015
- DUNS: 533070236

## Figures

- Devices: 44
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 36, EUDAMED 32, FDA 510(k) 4
- Device classes: FDA Class II 35, EU Class IIa 9
- EMDN [Z11 Bioimaging and radiotherapy instruments](https://devicerts.com/categories/emdn/Z11): 9 devices

## Sites and related companies

- Authorised representative: [Arazy Group GmbH](https://devicerts.com/representatives/arazy-group-gmbh-de-ar-000007685) (Germany)

## Devices

The first 44 of 44, in the order of the canonical page, which lists them all.

- [Viasonix 1.6MHz probe](https://devicerts.com/devices/viasonix-1-6mhz-probe-pvc0338) · ref PVC0338 · Class IIa · EUDAMED · status: Active
- [Viasonix 2 MHz PW Monitoring Doppler probe 5m cable](https://devicerts.com/devices/viasonix-2-mhz-pw-monitoring-doppler-probe-5m-cable-pvc0337) · ref PVC0337 · Class IIa · EUDAMED · status: Active
- [Dolphin Xpress](https://devicerts.com/devices/dolphin-xpress) · Class II · GUDID · status: Active
- [Viasonix 2MHz probe](https://devicerts.com/devices/viasonix-2mhz-probe-pvc0333) · ref PVC0333 · Class IIa · EUDAMED · status: Active
- [Viasonix 2 MHz PW Monitoring Doppler probe 2m cable](https://devicerts.com/devices/viasonix-2-mhz-pw-monitoring-doppler-probe-2m-cable-pvc0336) · ref PVC0336 · Class IIa · EUDAMED · status: Active
- [Dolphin MAX](https://devicerts.com/devices/dolphin-max) · Class II · EUDAMED, GUDID · status: Active
- [2 MHz monitoring, 5 meter cable](https://devicerts.com/devices/2-mhz-monitoring-2-mhz-monitoring-5-m) · Class II · EUDAMED, GUDID · status: Active
- [1.6 MHz probe](https://devicerts.com/devices/1-6-mhz-probe-1-6-mhz-probe) · Class II · EUDAMED, GUDID · status: Active
- [Dolphin 4D](https://devicerts.com/devices/dolphin-4d-f69618a2) · Class II · GUDID · status: Active
- [Pressure Cuff Size 2.5](https://devicerts.com/devices/pressure-cuff-size-2-5-pressure-cuff-size-2) · Class II · EUDAMED, GUDID · status: Active
- [4 MHz probe](https://devicerts.com/devices/4-mhz-probe-4-mhz-probe) · Class II · EUDAMED, GUDID · status: Active
- [Disk PPG sensor](https://devicerts.com/devices/disk-ppg-sensor-disk-ppg-sensor) · Class II · EUDAMED, GUDID · status: Active
- [Pressure Cuff Size 7](https://devicerts.com/devices/pressure-cuff-size-7-pressure-cuff-size-7) · Class II · EUDAMED, GUDID · status: Active
- [Fingerclip PPG sensor](https://devicerts.com/devices/fingerclip-ppg-sensor-fingerclip-ppg-senso) · Class II · GUDID · status: Active
- [8 MHz probe](https://devicerts.com/devices/8-mhz-probe-8-mhz-probe) · Class II · EUDAMED, GUDID · status: Active
- [Pressure Cuff Size 10](https://devicerts.com/devices/pressure-cuff-size-10-pressure-cuff-size-1) · Class II · EUDAMED, GUDID · status: Active
- [Toe Clip PPG Sensor](https://devicerts.com/devices/toe-clip-ppg-sensor-pvc0143) · Class II · EUDAMED, GUDID · status: Active
- [Pressure Cuff Size 12L](https://devicerts.com/devices/pressure-cuff-size-12l-pressure-cuff-size-1) · Class II · EUDAMED, GUDID · status: Active
- [LiteWalk Sandals Medium](https://devicerts.com/devices/litewalk-sandals-pvc0268-m) · Class II · GUDID · status: Active
- [LiteWalk Sandals Small](https://devicerts.com/devices/litewalk-sandals-pvc0268-s) · Class II · GUDID · status: Active
- [Pressure Cuff Size 1.6](https://devicerts.com/devices/pressure-cuff-size-1-6-pressure-cuff-size-1) · Class II · EUDAMED, GUDID · status: Active
- [2 MHz monitoring](https://devicerts.com/devices/2-mhz-monitoring-2-mhz-monitoring) · Class II · EUDAMED, GUDID · status: Active
- [Pressure Cuff Size 12](https://devicerts.com/devices/pressure-cuff-size-12-pressure-cuff-size-1) · Class II · EUDAMED, GUDID · status: Active
- [4 MHz probe](https://devicerts.com/devices/4-mhz-probe-pvc0330) · Class II · EUDAMED, GUDID · status: Active
- [Dolphin/XF Robot Accessory](https://devicerts.com/devices/dolphin-xf-robot-accessory-dolphin-xf-robot-acc) · Class II · EUDAMED, GUDID · status: Active
- [Detachable PPG Clip sensor](https://devicerts.com/devices/detachable-ppg-clip-sensor-detachable-ppg-clip) · Class II · EUDAMED, GUDID · status: Active
- [10 MHz probe](https://devicerts.com/devices/10-mhz-probe-pvc0332) · Class II · EUDAMED, GUDID · status: Active
- [Dolphin IQ](https://devicerts.com/devices/dolphin-iq-7551b871) · Class II · GUDID · status: Active
- [LiteWalk Sandals Large](https://devicerts.com/devices/litewalk-sandals-pvc0268-l) · Class II · GUDID · status: Active
- [Pressure Cuff Size 1.9](https://devicerts.com/devices/pressure-cuff-size-1-9-pressure-cuff-size-1) · Class II · EUDAMED, GUDID · status: Active
- [LiteWalk](https://devicerts.com/devices/litewalk-litewalk) · Class II · GUDID · status: Active
- [10 MHz probe](https://devicerts.com/devices/10-mhz-probe-10-mhz-probe) · Class II · EUDAMED, GUDID · status: Active
- [2 MHz probe](https://devicerts.com/devices/2-mhz-probe-2-mhz-probe) · Class II · EUDAMED, GUDID · status: Active
- [Dolphin IQ](https://devicerts.com/devices/dolphin-iq) · Class II · EUDAMED, GUDID · status: Active
- [8 MHz probe](https://devicerts.com/devices/8-mhz-probe-pvc0331) · Class II · EUDAMED, GUDID · status: Active
- [Dolphin/IQ, Dolphin/4D and Dolphin/MAX](https://devicerts.com/devices/dolphin-iq-dolphin-4d-and-dolphin-max-iyn) · ref K191023 · Class II · 510(k) · status: Active · decision 2019-05-16
- [LiteWalk](https://devicerts.com/devices/litewalk-irp) · ref K192607 · Class II · 510(k) · status: Active · decision 2019-12-19
- [Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory](https://devicerts.com/devices/dolphin-iq-dolphin-4d-and-dolphin-max-with-dolphin-xf-robot-iyn) · ref K202742 · Class II · 510(k) · status: Active · decision 2021-01-25
- [Dolphin/IQ and Dolphin/4D](https://devicerts.com/devices/dolphin-iq-and-dolphin-4d-iyn) · ref K170859 · Class II · 510(k) · status: Active · decision 2017-11-14
- [Falcon/Pro](https://devicerts.com/devices/falcon-pro-pvc0077) · ref PVC0077 · Class IIa · EUDAMED, GUDID · status: Active
- [Dolphin/4D](https://devicerts.com/devices/dolphin-4d-pvc0201) · ref PVC0201 · Class IIa · EUDAMED, GUDID · status: Active
- [Falcon/ABI+](https://devicerts.com/devices/falcon-abi-pvc0079) · ref PVC0079 · Class IIa · EUDAMED, GUDID · status: Active
- [Falcon/Xpress](https://devicerts.com/devices/falcon-xpress-pvc0400) · ref PVC0400 · Class IIa · EUDAMED, GUDID · status: Active
- [Falcon/Quad](https://devicerts.com/devices/falcon-quad-pvc0078) · ref PVC0078 · Class IIa · EUDAMED, GUDID · status: Active

## EU certificates

- 3903018CE01 · Quality management system · MDR · notified body DEKRA Certification B.V. · issued 2025-06-23 · expires 2028-01-01 · status: amended

## Source and citation

- Cite as: Viasonix Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/viasonix-ltd (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/viasonix-ltd.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/viasonix-ltd
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.