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MediByte Patient Kit

by BRAEBON Medical Corporation Canada EUDAMED

Ref 8111Model 8110

EMDN Z12100585

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B140PatientKit6H Basic UDI-DIDate10 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
8110, 8111
Primary DI / UDI-DI
B14081110
Basic UDI-DI
++B140PatientKit6H
EMDN Code
Z12100585 Polysomnography instruments - consumables
Device Class
Class I
Medical Purpose
Consumables to be used with the BRAEBON MediByte for HST.

Manufacturer details

EUDAMED SRN
CA-PR-000013743

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 3d06a3f3-508e-4ce1-a87a-bcb50bab6d7a 61 fields · synced 22 Oct 2026