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Bgi

by Bgi Europe a/S EUDAMED

Active European Union

Ref SAC2022002Model 25 tests/kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-SAC2022002E2 Basic UDI-DIDate14 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
D-Dimer Test(Colloidal Gold)
Model / Reference
25 tests/kit, SAC2022002
Primary DI / UDI-DI
D-SAC2022002E2
Basic UDI-DI
B-SAC2022002E2
EMDN Code
W0103020803 D-dimer - rt & poc
Device Class
Class IVD General
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

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No