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Genedian

by Hangzhou DIAN Biotechnology Co., Ltd. China EUDAMED

Ref L111-10125

EMDN W0105040619,W0105099099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-RA007UP Basic UDI-DIDate22 Sep 2022RegisteredStatusActive

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 24 Oct 2026

Device Name
COVID-19 Antigen Test Cassette
Model / Reference
L111-10125
Primary DI / UDI-DI
D-RA007UP
Basic UDI-DI
B-RA007UP
EMDN Code
W0105040619,W0105099099
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000007252
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hangzhou DIAN Biotechnology Co., Ltd.

See all devices from Hangzhou DIAN Biotechnology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 189e827d-53aa-48f6-a627-a0014ea5ead4 61 fields · synced 24 Oct 2026