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Covid-19 Antigen CARD Kit

by Fosun Diagnostics (Shanghai) Co., Ltd. EUDAMED

Active European Union

Ref 1.13.0045, 1.13.0046

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06931654312406 Basic UDI-DIDate9 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
1.13.0045, 1.13.0046
Primary DI / UDI-DI
06931654312406, 06931654312420
Basic UDI-DI
B-06931654312406, B-06931654312420
EMDN Code
W0105040619
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028169
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Fosun Diagnostics (Shanghai) Co., Ltd.

Properties

  • Sterile
  • Animal Tissues
  • Reagent
  • Self Testing

Other properties (6)

  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No