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CAIs Sensor

by BrainU Co., Ltd.

Ref CAIS-IFU-001Model CAIS-001

CAIs Sensor (CAIS-IFU-001) is a Class I device made by BrainU Co., Ltd., registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 88001313CAIs-001EW) with CE/MDR certificate 2026-MDR/QS-040 valid until 29 Jun 2031, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

29 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88001313CAIs-001EW Basic UDI-DI 08800131300015UDI-DIDate1 Jul 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-040 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    29 Jun 2026
    Expires
    29 Jun 2031

Timeline

3 dated events

  1. Certificate issued EUDAMED 2026-MDR/QS-040
  2. Registered EUDAMED 88001313CAIs-001EW
  3. Certificate expires EUDAMED 2026-MDR/QS-040

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
CAIS-001, CAIS-IFU-001
Primary DI / UDI-DI
08800131300015
Basic UDI-DI
88001313CAIs-001EW
EMDN code
N0101020101 EEG cortical electrodes
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
KR-MF-000033438
Authorised representative
Meridius Medical Europe Limited IE-AR-000004258

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Properties

  • Measuring function
Other properties (13, all answered No)