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Total IgE Rapid Quantitative Test（Fluorescence Immunoassay）

by WWHS Biotech.Inc China EUDAMED

Ref CP068.B1Model 25Tests/Kit EMDN W0103030399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975068490282 Basic UDI-DIDate4 Apr 2026RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
25Tests/Kit, CP068.B1
Primary DI / UDI-DI
06975068490282
Basic UDI-DI
B-06975068490282
EMDN Code
W0103030399 Antibody detection (immunohaematology) - other
Device Class
Class IVD General
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

See all devices from WWHS Biotech.Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Companion Diagnostics
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f26eaaf8-90df-4867-a5cb-fe3e6454a08a 61 fields · synced 22 Oct 2026