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Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR)

by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. EUDAMED 5 variants

Active European Union

Ref HWTS-RT177EModel HWTS-RT177A

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697484936RT177AVK Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
HWTS-RT177A, HWTS-RT177E
Primary DI / UDI-DI
06974849368727
Basic UDI-DI
697484936RT177AVK
EMDN Code
W0105070302 Other virus combinations - multiplex na reagents
Device Class
Class B
Market of Registration
Germany

Manufacturer details

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

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
  • Professional Testing

Other properties (9)

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