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Fluorescence Immunoassay Analyzer

by Hangzhou Alltest Biotech.Co., Ltd. EUDAMED

Active European Union

Ref AFR-400, AFR-200S, AFR-900, AFR-100, AFR-700Model Instrument

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number6970277510002PYF Basic UDI-DIDate20 Jul 2022RegisteredStatusActive
European UnionCE/IVDR Number6970277510002PYF Basic UDI-DIDate20 Jul 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, 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

Device Name
16-Channel Fluorescence Immunoassay Analyzer
Model / Reference
Instrument, AFR-400, AFR-200S, AFR-900, AFR-100, AFR-700
Primary DI / UDI-DI
06936983111034, 06936983107471, 06936983166515, 06970277512053, 06936983166492, 06942598223765
Basic UDI-DI
6970277510002PYF, 6970277510015PYV, B-06942598223765
Direct Marketing DI
06936983111034
06936983107471
06936983166515
06970277512053
06936983166492
EMDN Code
W0201020201, W0201069099
Device Class
Class A
Class IVD General
Market of Registration
Germany
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Near-Patient Testing YesEUDAMEDNoEUDAMED
  • Professional Testing
  • Surgical Instrument

Other properties (8)

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