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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

DENOPS-i

UDI-DI 08800053082655Basic UDI-DI 88000530AISU6

Class IIa · MDR · DENTIS CO., LTD

Identification
Model
AI100
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

IT353035

EU quality management system · valid

Notified body: BUREAU VERITAS ITALIA S.P.A. (1370)

Valid from 2026-05-26 · Expiry 2031-05-25

Scope not stated in certificate data.

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

Manufacturer

DENTIS CO., LTD

SRN KR-MF-000012523

KR · Daegu

manufacturer

Authorised representative: KTR Europe GmbH (DE-AR-000005685)

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/denops-i-2655 · UDI page: /udi/08800053082655

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