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Real time fluorescence quantitative PCR Device

by Wuxi Opulen Technology Co., Ltd. China EUDAMED

Ref 1722023Model OP-qPCR1600C EMDN W02050106

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697506157OPqPCR1600C65 Basic UDI-DIDate15 Sep 2022RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Model / Reference
OP-qPCR1600C, 1722023
Primary DI / UDI-DI
06975061571605
Basic UDI-DI
697506157OPqPCR1600C65
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023008
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Wuxi Opulen Technology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 517fea36-5f02-4fc0-b894-5610adc3a3fe 61 fields · synced 25 Oct 2026