Restricted

Snapshot 2026-10-17 · Link to EUDAMED

Primodent

UDI-DI +EPOLPRIT4LG108Basic UDI-DI ++EPOLAPTKB

Class IIa · MDR · Polident d.o.o. Industrija dentalnih proizvodov

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Identification

Model: Type 1/Type 2
EMDN: Q010699
Issuing agency: HIBCC
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR-0014

EU quality management system · restricted

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

Valid from 2026-06-24 · Expiry 2029-07-29

Scope not stated in certificate data.

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

Manufacturer

Polident d.o.o. Industrija dentalnih proizvodov

SRN SI-MF-000000740

SI · Volcja Draga

manufacturer

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Canonical device page: /device/primodent-%2Bepolprit4lg108 · UDI page: /udi/%2BEPOLPRIT4LG108

All devices from Polident d.o.o. Industrija dentalnih proizvodov

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