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Bio·Firm

by Zhejiang Wantaifu Biotechnology Co., Ltd China EUDAMED

Ref WI-MICR-C43A-10 EMDN W0105099007

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-WI-MICR-C43A-109N Basic UDI-DIDate28 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Dengue IgG/IgM and NS1 Rapid Test Device
Model / Reference
WI-MICR-C43A-10
Primary DI / UDI-DI
D-WI-MICR-C43A-109N
Basic UDI-DI
B-WI-MICR-C43A-109N
EMDN Code
W0105099007 Dengue - rt & poc
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000037582
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Zhejiang Wantaifu Biotechnology Co., Ltd

See all devices from Zhejiang Wantaifu Biotechnology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5e8c44d2-ef04-4214-814c-0bf221836a78 61 fields · synced 23 Oct 2026