Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

GORE® DrySeal Flex Introducer Sheath

UDI-DI 00733132628131Basic UDI-DI 0733132302562403W

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

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Identification

Model: GORE® DrySeal Flex Introducer Sheath
EMDN: C0502
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 764343

EU technical documentation assessment · unknown

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

Valid from 2026-08-20 · Expiry 2028-04-26

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)

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GORE® DrySeal Flex Introducer Sheath 00733132628148
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GORE® DrySeal Flex Introducer Sheath 00733132630042
GORE® DrySeal Flex Introducer Sheath 00733132628162

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Canonical device page: /device/gore-dryseal-flex-introducer-sheath-8131 · UDI page: /udi/00733132628131

All devices from W. L. Gore & Associates, Inc.

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