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SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)

by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. 4 variants

Ref HWTS-RT062H, HWTS-RT062D, HWTS-RT062EModel 1 test/kit (Nasopharyngeal swab), 1 test/kit (Rachenabstrichen), 10 tests/kit, 1 test/kit (Nasal Swab)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974849366129 Basic UDI-DI Date12 Aug 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  • Withdrawn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

Trade Name
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva
Model / Reference
1 test/kit (Nasopharyngeal swab), HWTS-RT062H, 1 test/kit (Rachenabstrichen), HWTS-RT062D, 10 tests/kit, HWTS-RT062E, 1 test/kit (Nasal Swab)
Primary DI / UDI-DI
06974849366129, 06974849366105, 06974849366501, 06974849366112
Basic UDI-DI
B-06974849366129, B-06974849366105, B-06974849366501, B-06974849366112
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000012807
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No