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COVID-19 Antigen Test Kit (Colloidal Gold Assay)

by Ningbo Beautiful Life Medical Biotechnology Development Co., Ltd.

Ref NBMLRS-XG-S5Model 20tests/box

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, self-declared

Class I: no certifier involved

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-16975783510026 Basic UDI-DI 16975783510026UDI-DIDate11 Oct 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
COVID-19 Antigen Test Kit (Colloidal Gold Assay)
Model / Reference
20tests/box, NBMLRS-XG-S5
Primary DI / UDI-DI
16975783510026
Basic UDI-DI
B-16975783510026
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000002185
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ningbo Beautiful Life Medical Biotechnology Development Co., Ltd.

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