Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Gladius

UDI-DI 04547327106399Basic UDI-DI 4547327DGW010NY

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

Scan an inventory CSV

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)

Related UDI-DIs

ASAHI Gaia PV 04547327106573
ASAHI Gaia PV 04547327106597
ASAHI Gaia PV 04547327106610
Astato 30 04547327073158
Astato 30 04547327073165
Astato XS 20 04547327082990
Gladius 04547327106368
Gladius 04547327106337
Gladius 04547327106429
Gladius MG14 PV 04547327124713
Gladius MG14 PV 04547327124683
Gladius MG14 PV ES 04547327124768

Showing 12 of 23 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/asahi-peripheral-guide-wire-asahi-gladius-6399 · UDI page: /udi/04547327106399

All devices from ASAHI INTECC CO., LTD.

Scan an inventory CSV