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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Ez3D-i

UDI-DI 08800019700401Basic UDI-DI 88000197SW002JX

Class IIa · MDR · Ewoosoft Co., Ltd.

Identification
Model
Ez3D-i
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

KR26/00000119

EU quality management system · unknown

Notified body: SGS Belgium NV (1639)

Valid from 2026-09-17 · Expiry 2031-09-03

Scope not stated in certificate data.

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

Manufacturer

Ewoosoft Co., Ltd.

SRN KR-MF-000013229

KR · Hwaseong-si, Gyeonggi-do

manufacturer

Authorised representative: VATECH GLOBAL FRANCE SARL (FR-AR-000009694)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ez3d-i-0401 · UDI page: /udi/08800019700401

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