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Upper Respiratory Tract Pathogen Nucleic Acid Detection Kit (Fluorescent PCR-Chip Method)

by Shenzhen Chenghui Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref CHE-URP26-101

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number697552996CHE-URP26-101NE Basic UDI-DIDate25 May 2026RegisteredStatusActive
European UnionCE/IVDR Number697552996CHE-URP26-101NE Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Upper Respiratory Tract Pathogen Nucleic Acid Detection Kit (Fluorescent PCR-Chip Method)
Upper Respiratory Tract Pathogen Nucleic Acid Detection Kit 1.1
Model / Reference
CHE-URP26-101
Primary DI / UDI-DI
06975529962617
Basic UDI-DI
697552996CHE-URP26-101NE, B-06975529962617
Direct Marketing DI
06975529962617
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class B
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000046638
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

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Properties

  • Reagent
  • Professional Testing
  • New Device

Other properties (8)

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