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Europa Ultra™

Certificate valid

Snapshot 2026-11-02 · Link to EUDAMED

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Class III · MDR · Rontis Corporation SA

Identification

Model
Europa Ultra™ Family
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No

Certificates

44912221174

EU technical documentation assessment · valid

Notified body: TÜV NORD CERT GmbH (0044)

Valid from 2024-03-15 · Expiry 2029-03-14

Scope not stated in certificate data.

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

Manufacturer

Rontis Corporation SA

SRN CH-MF-000031411

CH · Zug

manufacturer

Authorised representative: RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A. (GR-AR-000023077)

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Showing 12 of 53 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/europa-ultra-nc-non-compliant-coronary-balloon-catheter-2-75-0834 · UDI page: /udi/07630033300834

All devices from Rontis Corporation SA