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Fluorescence Immunoassay Analyzer

by Institute for Animal Health, Henan Academy of Agricultural Sciences EUDAMED

Active European Union

Ref RDR--3000-001Model CHFF3000

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number698036627CHFF3000E3A Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
CHFF3000, RDR--3000-001
Primary DI / UDI-DI
06980366273000
Basic UDI-DI
698036627CHFF3000E3A
Direct Marketing DI
06980366273000
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000059017
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Institute for Animal Health, Henan Academy of Agricultural Sciences

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