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Rapid Test Reader

by ACtest Biotech Co., Ltd. EUDAMED

Active European Union

Ref aca-A01

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6978274250000DG Basic UDI-DIDate14 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
aca-A01
Primary DI / UDI-DI
06978274250008
Basic UDI-DI
6978274250000DG
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000049724
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

Other devices from ACtest Biotech Co., Ltd.

See all devices from ACtest Biotech Co., Ltd. →

Properties

Show properties
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
  • New Device
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No