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SARS-COV-2 Antigen Rapid Tests for Self-Testing

by Beijing Lepu Medical Technology Co., Ltd. China EUDAMED

Ref CG3625Model CG3610 EMDN W0105040604

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06921807602942 Basic UDI-DIDate10 Jan 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  • Withdrawn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 22 Oct 2026

Model / Reference
CG3610, CG3625
Primary DI / UDI-DI
06921807602942
Basic UDI-DI
B-06921807602942
EMDN Code
W0105040604 Influenza & para influenza
Device Class
Class IVD devices for self-testing
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000033011
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Beijing Lepu Medical Technology Co., Ltd.

See all devices from Beijing Lepu Medical Technology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 0c6ce0c3-1475-4009-8e08-a5104ac23e47 61 fields · synced 22 Oct 2026