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Multichannel Fluorescence Quantitative Analyzer

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

Active European Union

Ref Y016BModel Fascan 48E, Fascan 48S, Fascan 16E, Fascan 16S

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697488477TLH014YY Basic UDI-DIDate10 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  • Withdrawn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
Multichannel Fluorescence Quantitative Analyzer
Model / Reference
Fascan 48E, Fascan 48S, Fascan 16E, Fascan 16S, Y016B
Primary DI / UDI-DI
06974884777713
Basic UDI-DI
697488477TLH014YY
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
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