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COVID-19 Antigen Detection Kit-Nasal swab

by New Gene (Hangzhou) Bioengineering Co., Ltd. 2 variants

Model COVID-19-NG21

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974108068818 Basic UDI-DI 06974108068818UDI-DIDate10 Jan 2023RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
COVID-19 Antigen Detection Kit-Nasal swab
Model / Reference
COVID-19-NG21
Primary DI / UDI-DI
06974108068818
Basic UDI-DI
B-06974108068818
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD devices for self-testing
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000013826
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from New Gene (Hangzhou) Bioengineering Co., Ltd.

Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No