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Dry Fluoroimmunoassay Analyzer

by WWHS Biotech.Inc China EUDAMED

Ref CP088.B1Model NIR-2000

EMDN W0202030201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6975068492010020T8 Basic UDI-DIDate4 Apr 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

Model / Reference
NIR-2000, CP088.B1
Primary DI / UDI-DI
06975068491005
Basic UDI-DI
6975068492010020T8
EMDN Code
W0202030201 Immunohematology readers
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000027179
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from WWHS Biotech.Inc

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
  • New Device
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No

Sources (1)

  • EUDAMED 60646a9b-0501-4803-bf3d-c6f049e1ac1b 61 fields · synced 22 Oct 2026