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TriClear CA/TV /GV Antigen Combo Rapid Test Kit

by Shenzhen Reagent Technology Co., Ltd. EUDAMED

Active European Union

Ref RNS92331Model 20T

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974443201468 Basic UDI-DIDate10 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
REAGEN TriClear CA / TV / GV Antigen Combo Rapid Test Kit
Model / Reference
20T, RNS92331
Primary DI / UDI-DI
06974443201468
Basic UDI-DI
B-06974443201468
EMDN Code
W0105070599 Multiple infectious - multiplex assays - other
Device Class
Class IVD General
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000047757
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Shenzhen Reagent Technology Co., Ltd.

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Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

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