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RSV/ADV Ag Rapid Test

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

Active European Union

Ref HWTS-RT201CModel HWTS-RT201A

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697484936HWTS-RT201A5C Basic UDI-DIDate10 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

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

    Technical documentation EU IVDR

    Notified body
    Notified body 3018
    Issued
    9 Jul 2026
    Expires
    9 Jul 2031

Specification

EUDAMED

Model / Reference
HWTS-RT201A, HWTS-RT201C
Primary DI / UDI-DI
06974849368956
Basic UDI-DI
697484936HWTS-RT201A5C
EMDN Code
W0105090699 Other multiple pathogens - 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