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UDI Compass
Certificate valid

Snapshot 2026-10-22 · Link to EUDAMED

KRYO ICE

UDI-DI 08055510560232Basic UDI-DI 805551056kryo_ice9H

Class IIa · MDR · Kaltek S.r.l.

Identification
Model
KRYO ICE
EMDN
M9001
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

IT348898

EU quality management system · valid

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

Valid from 2026-01-13 · Expiry 2030-01-12

Scope not stated in certificate data.

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

Manufacturer

Kaltek S.r.l.

SRN IT-MF-000019573

IT · Saonara (PD)

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/kryo-ice-0232 · UDI page: /udi/08055510560232

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