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Real-time Fluorescence Quantitative PCR lnstrument

by Wuxi Opulen Technology Co., Ltd. China EUDAMED

Model OPqPCR1600 EMDN W02050106

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697506157OPqPCR1600BL Basic UDI-DIDate23 Aug 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  • Withdrawn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 22 Oct 2026

Device Name
Real-time fluorecence quantitatine PCR instrument
Model / Reference
OPqPCR1600
Primary DI / UDI-DI
06975061571612
Basic UDI-DI
697506157OPqPCR1600BL
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023008
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wuxi Opulen Technology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
  • New Device
Other properties (4)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No

Sources (1)

  • EUDAMED d624931a-ebad-4cd9-bdd9-f340a16bfab4 61 fields · synced 22 Oct 2026