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Viasonix Ltd

Active in EUDAMED

Israelfrom SRN EUDAMED SRN IL-MF-000021015

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.

Devices
44
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 36
  • EUDAMED 32
  • FDA 510(k) 4

A device listed in two registries counts in both.

Device classes
  • FDA Class II 35
  • EU Class IIa 9
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN IL-MF-000021015
  • DUNS 533070236

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
Authorised rep.
Arazy Group GmbHDE

What Viasonix Ltd makes

Viasonix Ltd manufactures reusable blood pressure cuffs in multiple sizes, including 1.6, 1.9, 2.5, 7, 10, 12, and 12L, as well as general-purpose ultrasound imaging systems with 4 MHz and 8 MHz probes. Their ultrasound portfolio includes the Dolphin/IQ, Dolphin/4D, Dolphin/MAX, and LiteWalk models, alongside a detachable PPG clip sensor for monitoring.

The company’s devices are classified as Class II and Class IIa under EU and US regulations, with listings in the EUDAMED registry, FDA’s 510(k) clearance database, and the FDA’s Unique Device Identifier (UDI) system. Viasonix Ltd is based in Israel.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue44

Newest first, rows 1-44 of 44

Search and filter all 44 devices
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  • Viasonix 1.6MHz probe Ref PVC0338

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Viasonix 2 MHz PW Monitoring Doppler probe 5m cable Ref PVC0337

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dolphin Xpress

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Viasonix 2MHz probe Ref PVC0333

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Viasonix 2 MHz PW Monitoring Doppler probe 2m cable Ref PVC0336

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dolphin MAX

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • 2 MHz monitoring, 5 meter cable

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • 1.6 MHz probe

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Dolphin 4D

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Pressure Cuff Size 2.5

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • 4 MHz probe

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Disk PPG sensor

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Pressure Cuff Size 7

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Fingerclip PPG sensor

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 8 MHz probe

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Pressure Cuff Size 10

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Toe Clip PPG Sensor

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Pressure Cuff Size 12L

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • LiteWalk Sandals Medium

    Active Regimes: 510(k) Registry: GUDID Class:II

  • LiteWalk Sandals Small

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Pressure Cuff Size 1.6

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • 2 MHz monitoring

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Pressure Cuff Size 12

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • 4 MHz probe

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Dolphin/XF Robot Accessory

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Detachable PPG Clip sensor

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • 10 MHz probe

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Dolphin IQ

    Active Regimes: 510(k) Registry: GUDID Class:II

  • LiteWalk Sandals Large

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Pressure Cuff Size 1.9

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • LiteWalk

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10 MHz probe

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • 2 MHz probe

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Dolphin IQ

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • 8 MHz probe

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Dolphin/IQ, Dolphin/4D and Dolphin/MAX Ref K191023

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • LiteWalk Ref K192607

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory Ref K202742

    Active Regimes: CE MDR 510(k) Registry: 510(k) Class:II

  • Dolphin/IQ and Dolphin/4D Ref K170859

    Active Regimes: CE MDR 510(k) Registry: 510(k) Class:II

  • Falcon/Pro Ref PVC0077

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Dolphin/4D Ref PVC0201

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Falcon/ABI+ Ref PVC0079

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Falcon/Xpress Ref PVC0400

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIa

  • Falcon/Quad Ref PVC0078

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIa

Rows 1-44 of 44

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
IL-MF-000021015
DUNS number
533070236
EUDAMED status
Active
EUDAMED registered name
Viasonix Ltd.
EUDAMED abbreviated name
NA
Registered address
9, Dafna St., 4366223, Ra'ananna, Israel
PRRC contact
Adi Yosef(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 1 Jan 2028

EUDAMED certificates (1)

DEKRA Certification B.V. 0344 1 certificate

  • 3903018CE01 Active Amended

    Quality management system EU MDR

    Issued
    23 Jun 2025
    Expires
    1 Jan 2028
    Reason
    Mnf data change

Frequently asked questions

How many devices does VIASONIX LTD have in the registry?

The registry currently lists 44 devices for VIASONIX LTD. Devices recorded under merged duplicate company entries are counted once.

Which registries list VIASONIX LTD's devices?

Among its 44 most recently registered devices, VIASONIX LTD has devices listed in EUDAMED (32 devices), FDA 510(k) (4 devices) and FDA GUDID (36 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do VIASONIX LTD's devices fall under?

Among its 44 most recently registered devices, the classes recorded for VIASONIX LTD's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for VIASONIX LTD?

EUDAMED lists 1 certificate for VIASONIX LTD (quality management system) under MDR. The most recent was issued on 23 Jun 2025.

What are the newest devices from VIASONIX LTD in the registry?

The most recently registered devices listed for VIASONIX LTD include Viasonix 1.6MHz probe, Viasonix 2 MHz PW Monitoring Doppler probe 5m cable, Dolphin Xpress and Viasonix 2MHz probe.

Generated automatically from registry data and not verified by a human reviewer.