Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Gladius

UDI-DI 04547327106429Basic UDI-DI 4547327DGW010NY

Class IIa · MDR · ASAHI INTECC CO., LTD.

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Identification

Model: —
EMDN: C04020201
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

4202096CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-05-15 · Expiry 2028-08-25

Scope not stated in certificate data.

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

Manufacturer

ASAHI INTECC CO., LTD.

SRN JP-MF-000010199

JP · Seto

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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Showing 12 of 19 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/asahi-peripheral-guide-wire-asahi-gladius-6429 · UDI page: /udi/04547327106429

All devices from ASAHI INTECC CO., LTD.

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