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Orbit Headband

by Brainhero GmbH Austria EUDAMED

Ref HP_0098, HP_0098_2.0.0Model Headband

EMDN N01010203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number918000413ORBITHB016S Basic UDI-DIDate16 Jan 2024RegisteredStatusActive

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 Headband
Model / Reference
Headband, HP_0098, HP_0098_2.0.0
Primary DI / UDI-DI
09180004130086, 09180004130161
Basic UDI-DI
918000413ORBITHB016S
Direct Marketing DI
09180004130086
EMDN Code
N01010203 EEG headsets
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
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 7b5d4389-84f2-4907-ae54-1a2b45b08d1b 61 fields · synced 22 Oct 2026
  • EUDAMED 2e412b7a-a0d9-4f06-a1f2-67df6016f5c5 61 fields · synced 18 May 2026