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Bgi

by Bgi Europe a/S Denmark EUDAMED

Ref EU0200010001Model A1

EMDN W0201069099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5745000468EU02000100018D Basic UDI-DIDate27 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
BGI HY Fluorescence Immuno-analyzer
Model / Reference
A1, EU0200010001
Primary DI / UDI-DI
05745000468317
Basic UDI-DI
5745000468EU02000100018D
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 714a93cd-1ce3-4257-a36d-5efa78173406 61 fields · synced 22 Oct 2026