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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

DMject INSULINE SYRINGE

UDI-DI 08800109007014Basic UDI-DI 088001090DMjectF9

Class IIa · MDR · Shinchang Medical Co., Ltd.

Identification
Model
DMject INSULINE SYRINGE 0.3 ml 28G x 1/2"
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

2025-MDR/QS-014

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2025-02-14 · Expiry 2030-02-14

Scope not stated in certificate data.

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

Manufacturer

Shinchang Medical Co., Ltd.

SRN KR-MF-000012650

KR · Gumi-city, Gyeongsangbuk-do

manufacturer

Authorised representative: Javitech Consulting GmbH (DE-AR-000045915)

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/dmject-insuline-syringe-7014 · UDI page: /udi/08800109007014

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