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Dry Biochemistry Immunoassay Analyzer

by WWHS Biotech.Inc China EUDAMED

Ref CP119.B1Model NIR-2000C EMDN W0201069099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6975068492040010U6 Basic UDI-DIDate4 Apr 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
NIR-2000C, CP119.B1
Primary DI / UDI-DI
06975068491227
Basic UDI-DI
6975068492040010U6
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A

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 109b3a55-f7d0-4329-99ce-c820fbf12c0e 61 fields · synced 23 Oct 2026