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SARS‐CoV‐2 Antigen Rapid Test Kit

by Shenzhen Lvshiyuan Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref HM048A

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697416967HM048AKU Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
SARS‐CoV‐2 Antigen Rapid Test Kit
Model / Reference
HM048A
Primary DI / UDI-DI
06974169670050
Basic UDI-DI
697416967HM048AKU
Direct Marketing DI
06974169670050
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028164
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Shenzhen Lvshiyuan Biotechnology Co., Ltd.

See all devices from Shenzhen Lvshiyuan Biotechnology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No