Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Comfort-in

UDI-DI 08809230108997Basic UDI-DI 880923010Comfort-inMQ

Class IIb · MDR · MIKA Medical Co.

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Identification

Model: —
EMDN: A99
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: Yes
Reusable surgical: No

Certificates

2023-MDR/QS-045

EU quality management system · valid

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

Valid from 2023-11-10 · Expiry 2028-11-10

Scope not stated in certificate data.

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

Manufacturer

MIKA Medical Co.

SRN KR-MF-000019144

KR · Busan

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

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Showing 12 of 24 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/comfort-in-8997 · UDI page: /udi/08809230108997

All devices from MIKA Medical Co.

Scan an inventory CSV