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Okti Event Button

by Compumedics Limited

Ref 7029-0001-01

Okti Event Button (7029-0001-01) is a Class I device made by Compumedics Limited, registered in EUDAMED on 11 Oct 2026 (Basic UDI-DI 9342451EVB-2V), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9342451EVB-2V Basic UDI-DI 09342451006677UDI-DIDate11 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Event Button
Model / reference
7029-0001-01
Primary DI / UDI-DI
09342451006677
Basic UDI-DI
9342451EVB-2V
EMDN code
Z12100385 Electroencephalography instruments - consumables
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000050437
Authorised representative
Compumedics EUROPE GmbH DE-AR-000039096

Other devices from Compumedics Limited

See all devices from Compumedics Limited →

Properties

Other properties (14, all answered No)