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Chemtrue ®® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)

by Shanghai Chemtron Biotech Co., Ltd.

Ref 8045C, GS110133C25Model 25 tests/kit

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-CNM0000180720005LW Basic UDI-DI Date8 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  • Withdrawn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/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)
COVID-19/Influenza A&B/ADV Antigen Rapid Test
Model / Reference
8045C, 25 tests/kit, GS110133C25
Primary DI / UDI-DI
D-CNM0000180720005LW, 06977903345122
Basic UDI-DI
B-CNM0000180720005LW, B-06977903345122
EMDN Code
W0105900299, W0105090699
Device Class
Class IVD General
EU market of registration
Austria
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000018072
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (8)

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