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Multichannel Fluorescence Quantitative Analyzer

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

Ref Y016AModel Fascan 48E, Fascan 48S, Fascan 16E, Fascan 16S

EMDN W02050199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697488477TLH014YY Basic UDI-DIDate10 Jul 2023RegisteredStatusActive

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
Multichannel Fluorescence Quantitative Analyzer
Model / Reference
Fascan 48E, Fascan 48S, Fascan 16E, Fascan 16S, Y016A
Primary DI / UDI-DI
06974884777720
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

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 8316a94e-f20d-498f-8279-06909cb34816 61 fields · synced 24 Oct 2026