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Fluorescence Immunoassay Analyzer

by Hangzhou Alltest Biotech.Co., Ltd. China EUDAMED

Ref AFR-702Model Instrument

EMDN W0201020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6970277510012UYW Basic UDI-DIDate6 Jun 2025RegisteredStatusUnknown

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Status not known
  • Not covered

European Union — CE/IVDR Status not known

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Instrument, AFR-702
Primary DI / UDI-DI
06942598200698
Basic UDI-DI
6970277510012UYW, 6970277510044WZP
Direct Marketing DI
06942598200698
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • 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

Sources (2)

  • EUDAMED 8842db5c-ad2d-4a6a-80c1-b9c163e759ca 61 fields · synced 22 Oct 2026
  • EUDAMED 06942598200698|6970277510044WZP 61 fields · synced 19 Jun 2026