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Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

GORE® CARDIOFORM Septal Occluder

UDI-DI 00733132617661Basic UDI-DI 0733132200623432B

Class III · MDR · W. L. Gore & Associates, Inc.

Identification
Model
GORE® CARDIOFORM Septal Occluder
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR 731002

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-08-17 · Expiry 2031-08-16

Scope not stated in certificate data.

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

Manufacturer

W. L. Gore & Associates, Inc.

SRN US-MF-000001141

US · Flagstaff, Arizona

manufacturer

Authorised representative: W.L. Gore & Associates B.V. (NL-AR-000000168)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/gore-cardioform-septal-occluder-7661 · UDI page: /udi/00733132617661

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