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Fluorescence immunoassay analyzer

by Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd. China EUDAMED

Ref 2109Model IF208/IF201/IF101 EMDN W02010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69781984802001A4 Basic UDI-DIDate15 Jan 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  • Withdrawn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 · synced 23 Oct 2026

Model / Reference
IF208/IF201/IF101, 2109
Primary DI / UDI-DI
06978198481090
Basic UDI-DI
69781984802001A4
Direct Marketing DI
06978198481090
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000046524
Authorised representative
Medunion S.L. ES-AR-000019366

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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 (1)

  • EUDAMED 6f6b949f-c9a5-4758-b16c-fd7e8aced013 61 fields · synced 23 Oct 2026