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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Europa Ultra™

UDI-DI 07630033300964Basic UDI-DI 076300333EF_CBLCATHGG

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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Canonical device page: /device/europa-ultra-nc-non-compliant-coronary-balloon-catheter-4-0m-0964 · UDI page: /udi/07630033300964

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