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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

SOLARIS VASCULAR STENT GRAFT

UDI-DI 07908249704259Basic UDI-DI 79082497SOLARISCB

Class IIb · MDR · Scitech Produtos Médicos SA

Identification
Model
SOLARIS VASCULAR STENT GRAFT
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2025-MDR/TD-015

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-015

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)

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Canonical device page: /device/solaris-vascular-stent-graft-4259 · UDI page: /udi/07908249704259

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