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Orbit

by Brainhero GmbH Austria EUDAMED

Ref HP_0104

EMDN Z12100801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number918000413OrbitND Basic UDI-DIDate17 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Orbit
Model / Reference
HP_0104
Primary DI / UDI-DI
09180004130079
Basic UDI-DI
918000413OrbitND
Direct Marketing DI
09180004130079
EMDN Code
Z12100801 EEG telemetry systems
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000022440

Other devices from Brainhero GmbH

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f380b0aa-e730-4b35-9d36-f4dd361167ca 61 fields · synced 22 Oct 2026