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Fast Real-time Fluorescence PCR Analyzer

by BioTeke Corporation（Wuxi）Co., Ltd China EUDAMED

Ref BTK-8Model BTK-8, BTK-1 EMDN W02050301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697454156006L5 Basic UDI-DIDate9 Jun 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Fast Real-time Fluorescence PCR Analyzer
Model / Reference
BTK-8, BTK-1
Primary DI / UDI-DI
06974541565202
Basic UDI-DI
697454156006L5
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000007517
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Bioteke Corporation (Wuxi) Co., Ltd.

See all devices from Bioteke Corporation (Wuxi) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 06974541565202|697454156006L5 61 fields · synced 24 Oct 2026