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Chikungunya IgG/IgM Rapid Test

by Hangzhou Immuno Biotech Co., Ltd China EUDAMED

Ref HCHI012TModel Chikungunya IgG/IgM Rapid Test

EMDN W0105040525

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974238910155 Basic UDI-DIDate4 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Chikungunya IgG/IgM Rapid Test, HCHI012T
Primary DI / UDI-DI
06974238910155
Basic UDI-DI
B-06974238910155
EMDN Code
W0105040525 Chikungunya virus - na reagents
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001118
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Hangzhou Immuno Biotech Co., Ltd

See all devices from Hangzhou Immuno Biotech Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f00ea82c-1103-46c4-bb3f-3e2abbc59b34 61 fields · synced 22 Oct 2026