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Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Fenix

UDI-DI 08059575510010Basic UDI-DI 805957551FENIXSUITE20228C

Class IIa · MDR · EL.CO. S.r.l.

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

EPT 0477.MDR.22/4997.1

EU quality management system · valid

Notified body: Eurofins Product Testing Italy S.r.l. (0477)

Valid from 2025-05-29 · Expiry 2027-11-28

Scope not stated in certificate data.

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

Manufacturer

EL.CO. S.r.l.

SRN IT-MF-000029405

IT · Cairo Montenotte

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fenix-0010 · UDI page: /udi/08059575510010

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