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Real-time PCR System

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

Ref Y059HModel Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R

EMDN W02050106

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697488477TLH015Z2 Basic UDI-DIDate4 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Real-time PCR System
Model / Reference
Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R, Y059H
Primary DI / UDI-DI
06974884777621
Basic UDI-DI
697488477TLH015Z2
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

Other devices from Xi'an Tianlong Science and Technology Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED b037c162-bf23-49da-b557-725fc2b414c4 61 fields · synced 22 Oct 2026