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Real-time PCR System

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

Active European Union

Ref Y010HModel 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  • Withdrawn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

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

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, Y010H
Primary DI / UDI-DI
06974884777973
Basic UDI-DI
697488477TLH001YP
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
Market of Registration
Austria

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