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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

INTRODUCER

UDI-DI 08052286590289Basic UDI-DI 805228659EIAG20020xxxLB

Class IIa · MDR · ELESTA SpA

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

IT343885

EU quality management system · valid

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

Valid from 2025-07-09 · Expiry 2030-07-08

Scope not stated in certificate data.

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

Manufacturer

ELESTA SpA

SRN IT-MF-000037909

IT · CALENZANO

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/introducer-0289 · UDI page: /udi/08052286590289

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