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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Acure Electrolysis 8000

UDI-DI 05425022614526Basic UDI-DI 5425022610500SB

Class IIa · MDR · GymnaUniphy N.V.

Identification
Model
Devices for electrolysis and dry needling
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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/acure-electrolysis-8000-4526 · UDI page: /udi/05425022614526

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