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Real-time PCR System

by Xi'an Tianlong Science and Technology Co., Ltd. EUDAMED

Active European Union

Ref Y012H-01Model Gentier 48E, Gentier 48R, Gentier 96E, Gentier 96T, Gentier 96R, Gentier Mini, Gentier mini+, Gentier X3E, Gentier X3R, Gentier X3S, Gentier X3C, FLUORITE, PowerAmp96™ Dx

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697488477TLH001YP Basic UDI-DIDate11 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Real-time PCR System
Model / Reference
Gentier 48E, Gentier 48R, Gentier 96E, Gentier 96T, Gentier 96R, Gentier Mini, Gentier mini+, Gentier X3E, Gentier X3R, Gentier X3S, Gentier X3C, FLUORITE, PowerAmp96™ Dx, Y012H-01
Primary DI / UDI-DI
06974884777577
Basic UDI-DI
697488477TLH001YP
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001079
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No