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SARS‐CoV‐2 Antigen Rapid Test Kit

by Shenzhen Lvshiyuan Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref 10 sets

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-16974169670040 Basic UDI-DIDate7 Nov 2022RegisteredStatusActive

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  • Withdrawn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

Model / Reference
10 sets
Primary DI / UDI-DI
16974169670040
Basic UDI-DI
B-16974169670040
EMDN Code
W0105040519
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000028164
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Shenzhen Lvshiyuan Biotechnology Co., Ltd.

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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