Skip to content

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

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

Active European Union

Ref HWTS-EVO32HLModel HWTS-EV032A

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697484936HWTS-EV032AYS Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

Device Name
Nucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR)
Model / Reference
HWTS-EV032A, HWTS-EVO32HL
Primary DI / UDI-DI
06974849369779
Basic UDI-DI
697484936HWTS-EV032AYS
Direct Marketing DI
06974849369779
EMDN Code
W0105011802 C.difficile toxin a/b detection
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