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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

CAIs Sensor

UDI-DI 08800131300015Basic UDI-DI 88001313CAIs-001EW

Class Im · MDR · BrainU Co.,Ltd.

Identification
Model
CAIS-001
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

2026-MDR/QS-040

EU quality management system · valid

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

Valid from 2026-06-29 · Expiry 2031-06-29

Scope not stated in certificate data.

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

Manufacturer

BrainU Co.,Ltd.

SRN KR-MF-000033438

KR · Seongnam-si, Gyeonggi-do

manufacturer

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

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/cais-sensor-0015 · UDI page: /udi/08800131300015

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