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2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)

by Jiangsu Mole Bioscience Co., LTD. EUDAMED

Active European Union

Ref R401T010B0C2

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970895476195 Basic UDI-DIDate9 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  • Withdrawn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
2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
Model / Reference
R401T010B0C2
Primary DI / UDI-DI
06970895476195
Basic UDI-DI
B-06970895476195
EMDN Code
W0105041106 Coronavirus - na reagents
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000001539
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Reagent
  • Professional Testing

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