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COVID-19/ Flu A&B Ag Rapid Test

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

Ref HWTS-RT200BModel HWTS-RT200A

Active European Union

CE IVDR

Valid until

9 Jul 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Kiwa Sertio Oy

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/IVDR Number697484936HWTS-RT200A59 Basic UDI-DIDate10 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EU-TDA-FI-92654-800162-2026 Active

    Technical documentation EU IVDR

    Notified body
    Kiwa Sertio Oy 3018
    Issued
    9 Jul 2026
    Expires
    9 Jul 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
HWTS-RT200A, HWTS-RT200B
Primary DI / UDI-DI
06974849368901
Basic UDI-DI
697484936HWTS-RT200A59
EMDN Code
W0105090601 Coronavirus / influenza - rt & poc
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000012807
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

See all devices from Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. →

Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing
  • New Device

Other properties (7)

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