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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Freehand ZOOM Module

UDI-DI 03830088730028Basic UDI-DI 383008873ZOOM01KK

Class Is · MDR · MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR-0044

EU quality management system · valid

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ (1304)

Valid from 2026-06-30 · Expiry 2031-06-29

Scope not stated in certificate data.

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

Manufacturer

MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o.

SRN SI-MF-000048191

SI · Novo mesto

manufacturer

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/freehand-zoom-module-0028 · UDI page: /udi/03830088730028

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