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SARS-CoV-2 Antigen Rapid Test kit

by Nantong EgensBiotechnology Co., Ltd.

Ref SARS-CoV-2 Antigen cassette

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-693757995100QF Basic UDI-DI D-693757995100QFUDI-DIDate14 Nov 2023RegisteredStatusWithdrawn No longer placed on the EU market

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Model / Reference
SARS-CoV-2 Antigen cassette
Primary DI / UDI-DI
D-693757995100QF
Basic UDI-DI
B-693757995100QF
EMDN Code
W0105040699 Viral antigen/antibody detection - other
Device Class
Class IVD devices for self-testing

Manufacturer details

EUDAMED SRN
CN-MF-000021561
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Nantong EgensBiotechnology Co., Ltd.

See all devices from Nantong EgensBiotechnology Co., Ltd. →

Properties

  • Self Testing
  • Professional Testing

Other properties (8)

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