Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Clear-Jet Injection Catheter

UDI-DI 08809327355686Basic UDI-DI 0880932735EIGB

Class IIa · MDR · FINEMEDIX CO., LTD.

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Identification

Model: FM-EI0002(1800)(0.05T)C
EMDN: K0199
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2026-MDR/QS-030

EU quality management system · valid

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

Valid from 2026-06-02 · Expiry 2031-06-02

Scope not stated in certificate data.

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

Manufacturer

FINEMEDIX CO., LTD.

SRN KR-MF-000021680

KR · Daegu

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/clear-jet-injection-catheter-5686 · UDI page: /udi/08809327355686

All devices from FINEMEDIX CO., LTD.

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