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Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

SION black

UDI-DI 04547327089630Basic UDI-DI 4547327BGW011N8

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

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

4202096TD09

EU technical documentation assessment · valid

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

Valid from 2025-09-26 · Expiry 2030-09-26

Scope not stated in certificate data.

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

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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Canonical device page: /device/asahi-ptca-guide-wire-asahi-sion-black-190cm-j-9630 · UDI page: /udi/04547327089630

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