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Automatic Nucleic Acid Extractor

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

Ref Y963HModel Npex 96

EMDN W02050106

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697488477TLH019ZA Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Automatic Nucleic Acid Extractor
Model / Reference
Npex 96, Y963H
Primary DI / UDI-DI
06974884776198
Basic UDI-DI
697488477TLH019ZA
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

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 06974884776198|697488477TLH019ZA 61 fields · synced 24 Oct 2026