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Human CYP2C19 Genotyping Detection Kit (PCR-Melting Curve Method)

by Wuxi Ruiqi Gene Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref P128H, P153H

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974870710090 Basic UDI-DIDate26 Sep 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  • Withdrawn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
Human CYP2C19 Genotyping Detection Kit (PCR-Melting Curve Method)
Model / Reference
P128H, P153H
Primary DI / UDI-DI
06974870710090, 06974870710144
Basic UDI-DI
B-06974870710090, B-06974870710144
EMDN Code
W0106030102 Cyp 450 - multiple tests on micro-arrays
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000027697
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

Show 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