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by GVB-geliMED GmbH EUDAMED

Active European Union

Ref M-E-I3-1425-15, M-E-SXS-2025-15, M-E-SXS-2125-15, M-E-XLL-2125-15, M-E-M-2125-15, M-E-I1-2025-15, M-E-M-2025-15, M-E-XS-2025-15, M-E-LM-2525-15-25244, M-E-XS-2125-15, M-E-L-2125-15, M-E-M-2525-15-25244, M-E-I2-2025-15, M-E-LM-2125-15, M-E-L-2025-15, M-E-MS-2125-15, M-E-I2-1525-15, M-E-I2-2125-15

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number40491790001MU Basic UDI-DIDate2 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
EEG Hauben
Model / Reference
M-E-I3-1425-15, M-E-SXS-2025-15, M-E-SXS-2125-15, M-E-XLL-2125-15, M-E-M-2125-15, M-E-I1-2025-15, M-E-M-2025-15, M-E-XS-2025-15, M-E-LM-2525-15-25244, M-E-XS-2125-15, M-E-L-2125-15, M-E-M-2525-15-25244, M-E-I2-2025-15, M-E-LM-2125-15, M-E-L-2025-15, M-E-MS-2125-15, M-E-I2-1525-15, M-E-I2-2125-15
Primary DI / UDI-DI
04049179002039, 04049179002060, 04049179002077, 04049179003593, 04049179043131, 04049179001681, 04049179000981, 04049179002114, 04049179005863, 04049179004989, 04049179003562, 04049179005870, 04049179002015, 04049179003586, 04049179001810, 04049179003579, 04049179002008, 04049179002022
Basic UDI-DI
40491790001MU
Direct Marketing DI
04049179002039
04049179002060
04049179002077
04049179003593
04049179043131
04049179001681
04049179000981
04049179002114
04049179005863
04049179004989
04049179003562
04049179005870
04049179002015
04049179003586
04049179001810
04049179003579
04049179002008
04049179002022
EMDN Code
N01010203 EEG headsets
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005314

Other devices from GVB-geliMED GmbH

See all devices from GVB-geliMED GmbH →

Properties

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