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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

ASAHI Gaia Next 2

UDI-DI 04547327138925Basic UDI-DI 4547327DGW001NX

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

4202096TD01

EU technical documentation assessment · valid

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

Valid from 2023-08-25 · Expiry 2028-08-25

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)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/asahi-gaia-next-2-8925 · UDI page: /udi/04547327138925

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