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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Giant S-AT Balloon Catheter

UDI-DI 07908249704242Basic UDI-DI 79082497GIANTVD

Class III · MDR · Scitech Produtos Médicos SA

Identification
Model
GIANT S-AT BALLOON CATHETER
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

2025-MDR/TD-016

EU technical documentation assessment · valid

Notified body: 3EC International a.s. (2265)

Valid from 2025-02-07 · Expiry 2030-02-07

Scope not stated in certificate data.

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

2025-MDR/QS-016

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2025-02-07 · Expiry 2030-02-07

Scope not stated in certificate data.

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

Manufacturer

Scitech Produtos Médicos SA

SRN BR-MF-000018627

BR · Aparecida de Goiânia, Goiás

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/giant-s-at-balloon-catheter-4242 · UDI page: /udi/07908249704242

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