Skip to content

BioScan 1.0

by MEDDI hub a.s. Czech Republic EUDAMED

Ref N/A

EMDN Z12030292

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859423233BIOSCAN01GQ Basic UDI-DIDate2 Apr 2026RegisteredStatusActive

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
N/A
Primary DI / UDI-DI
08594232330001
Basic UDI-DI
859423233BIOSCAN01GQ
EMDN Code
Z12030292 Vital signs monitoring instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000036762

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 (1)

  • EUDAMED eb451805-7910-4e1b-b95a-edbbec6159cb 61 fields · synced 22 Oct 2026