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Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)

by Daan Gene Co., Ltd. EUDAMED

Active European Union

Ref DA0203Model Single tube, 20 tests/kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06928103002032 Basic UDI-DIDate18 Nov 2022RegisteredStatusActive

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  • Withdrawn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
Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)
Model / Reference
Single tube, 20 tests/kit, DA0203
Primary DI / UDI-DI
06928103002032
Basic UDI-DI
B-06928103002032
EMDN Code
W0105040505 Respiratory syncytial virus (rsv) - na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025799
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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