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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

EZ-CloseTM

UDI-DI 08800021610477Basic UDI-DI 88000216EZ9W

Class III · MDR · Medical Impact

Identification
Model
EZK01, EZK02, EZK03
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2024-MDR/TD-052/A

EU technical documentation assessment · unknown

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

Valid from 2026-01-14 · Expiry 2029-08-28

Scope not stated in certificate data.

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

2024-MDR/QS-052/A

EU quality management system · unknown

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

Valid from 2026-01-14 · Expiry 2029-08-28

Scope not stated in certificate data.

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

Manufacturer

Medical Impact

SRN KR-MF-000030613

KR · Bucheon-si, Gyeonggi-do

manufacturer

Authorised representative: Meridius Medical Europe Limited (IE-AR-000004258)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ez-closetm-0477 · UDI page: /udi/08800021610477

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