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Isothermal Amplification Fluorescence Detector

by Wuxi Qitian Biological Science Instrument Co., Ltd. EUDAMED

Active European Union

Ref 828Model RAA-F1628

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697519654828QA Basic UDI-DIDate22 May 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  • Withdrawn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

Device Name
Isothermal Amplification Fluorescence Detector
Model / Reference
RAA-F1628, 828
Primary DI / UDI-DI
06975196540057
Basic UDI-DI
697519654828QA
Direct Marketing DI
06975196540057
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023012
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wuxi Qitian Biological Science Instrument Co., Ltd.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No