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FT-PRO Flow-through System

by DiagCor Life Science Limited Hong Kong EUDAMED

Ref 92002Model 92002

EMDN W02050101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number489703692920024F Basic UDI-DIDate22 May 2026RegisteredStatusActive

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
FT-PRO Flow-through System
Model / Reference
92002
Primary DI / UDI-DI
04897036920022
Basic UDI-DI
489703692920024F
EMDN Code
W02050101 Nucleic acid hybridization units
Device Class
Class A
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
HK-MF-000045806
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from DiagCor Life Science Limited

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 82039378-a528-4ce3-8e70-8af31948481d 61 fields · synced 22 Oct 2026