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Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

CardioExpress 4012

UDI-DI 08809276944269Basic UDI-DI 880927694CQ57NE

Class IIa · MDR · Bionet Co., Ltd.

Identification
Model
Cardio Q50 / Cardio Q70
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

2024-MDR/QS-053/A

EU quality management system · unknown

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

Valid from 2026-03-10 · Expiry 2029-09-12

Scope not stated in certificate data.

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

Manufacturer

Bionet Co., Ltd.

SRN KR-MF-000013439

KR · Seoul

manufacturer

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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cardioexpress-4012-4269 · UDI page: /udi/08809276944269

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