Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Elexeo Ultrasound control

UDI-DI 05425022614922Basic UDI-DI 5425022610106S3

Class IIa · MDR · GymnaUniphy N.V.

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Identification

Model: Device for multiple non-invasive electrophysical modalities
EMDN: Z12069099
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2257802CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-05-22 · Expiry 2028-10-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

GymnaUniphy N.V.

SRN BE-MF-000001786

BE · Bilzen

manufacturer

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Elexeo Electrotherapy module 05425022614946
Elexeo Ultrasound module 05425022614960
Elexeo Vaco module 05425022614984

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/elexeo-ultrasound-control-4922 · UDI page: /udi/05425022614922

All devices from GymnaUniphy N.V.

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