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Cuffie EEG

by Bionen SRL EUDAMED

Active European Union

Ref 0013.C05-BEL-S-E, 0013.F02-NKH-K-E-21, 0013.C02-BQK-S-E-11, 0013.F03-BPP-K-I, 0013.C06-UNI-S-I, 0013.C03-BPP-S-I, 0013.C02-BEM-S-E-21, 0013.F02-BEL-K-E, 0013.C03-NEM-S-E, 0013.C05-UNI-S-E, 0013.F02-BQK-S-I-21, 0013.C02-BQK-S-I, 0013.C05-BQK-S-E, 0013.C04-MBE-K-E, 0013.C05-NKH-K-I, 0013.C02-BQK-S-E, 0013.C02-NKH-S-I-21, 0013.F01-BEL-K-E, 0013.C02-NKH-S-I, 0013.C05-MBE-S-E-37, 0013.F02-BEL-S-I-21, 0013.C05-UNI-S-E-64, 0013.F03-BEL-S-I, 0013.C04-BEL-K-E, 0013.C06-BPP-S-I, 0013.C04-BPP-S-E, 0013.F01-BEL-S-I, 0013.C01-BPP-S-I, 0013.C05-CWL-S-E, 0013.C04-BQK-K-E, 0013.F01-UNI-S-I, 0013.F01-BPP-K-E-21, 0013.F02-NKH-S-E, 0013.C06-NKH-S-I, 0013.C03-UNI-S-I, 0013.C06-NKH-K-E, 0013.C04-BQK-S-E, 0013.C06-BPP-S-E-64, 0013.C05-BQK-S-I, 0013.F02-BEL-S-I, 0013.F01-BQK-S-I, 0013.C03-BEL-K-E-21, 0013.C03-BQK-S-E-21, 0013.C03-BEL-S-I, 0013.C05-B36-S-E, 0013.C04-BPP-S-I, 0013.F03-BPP-S-E-21, 0013.C05-MBE-S-E, 0013.C04-NKH-S-E, 0013.C03-BQK-S-I-21, 0013.C05-BPP-K-E

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033315120013RN Basic UDI-DIDate12 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
0013.C05-BEL-S-E, 0013.F02-NKH-K-E-21, 0013.C02-BQK-S-E-11, 0013.F03-BPP-K-I, 0013.C06-UNI-S-I, 0013.C03-BPP-S-I, 0013.C02-BEM-S-E-21, 0013.F02-BEL-K-E, 0013.C03-NEM-S-E, 0013.C05-UNI-S-E, 0013.F02-BQK-S-I-21, 0013.C02-BQK-S-I, 0013.C05-BQK-S-E, 0013.C04-MBE-K-E, 0013.C05-NKH-K-I, 0013.C02-BQK-S-E, 0013.C02-NKH-S-I-21, 0013.F01-BEL-K-E, 0013.C02-NKH-S-I, 0013.C05-MBE-S-E-37, 0013.F02-BEL-S-I-21, 0013.C05-UNI-S-E-64, 0013.F03-BEL-S-I, 0013.C04-BEL-K-E, 0013.C06-BPP-S-I, 0013.C04-BPP-S-E, 0013.F01-BEL-S-I, 0013.C01-BPP-S-I, 0013.C05-CWL-S-E, 0013.C04-BQK-K-E, 0013.F01-UNI-S-I, 0013.F01-BPP-K-E-21, 0013.F02-NKH-S-E, 0013.C06-NKH-S-I, 0013.C03-UNI-S-I, 0013.C06-NKH-K-E, 0013.C04-BQK-S-E, 0013.C06-BPP-S-E-64, 0013.C05-BQK-S-I, 0013.F02-BEL-S-I, 0013.F01-BQK-S-I, 0013.C03-BEL-K-E-21, 0013.C03-BQK-S-E-21, 0013.C03-BEL-S-I, 0013.C05-B36-S-E, 0013.C04-BPP-S-I, 0013.F03-BPP-S-E-21, 0013.C05-MBE-S-E, 0013.C04-NKH-S-E, 0013.C03-BQK-S-I-21, 0013.C05-BPP-K-E
Primary DI / UDI-DI
08033315129281, 08033315128147, 08033315129267, 08033315128192, 08033315129632, 08033315129977, 08033315126273, 08033315126822, 08033315123203, 08033315121124, 08033315127270, 08033315128888, 08033315129236, 08033315129656, 08033315121681, 08033315129915, 08033315120035, 08033315126686, 08033315129830, 08033315129922, 08033315128543, 08033315121452, 08033315126792, 08033315129212, 08033315121070, 08033315126297, 08033315126785, 08033315120752, 08033315123623, 08033315122404, 08033315128604, 08033315120905, 08033315128024, 08033315129878, 08033315129670, 08033315129694, 08033315129243, 08033315121568, 08033315129557, 08033315126877, 08033315127607, 08033315129892, 08033315122725, 08033315129311, 08033315129441, 08033315121001, 08033315121544, 08033315129410, 08033315129328, 08033315123098, 08033315122923
Basic UDI-DI
8033315120013RN
EMDN Code
N01010203 EEG headsets
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018461

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Properties

Show 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