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CHK Biotech

by Shanghai Chuangkun Biotech Inc. EUDAMED

Active European Union

Model Q9600 Q1600

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697601464RFQPS012B Basic UDI-DIDate7 Feb 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  • Withdrawn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
Real-time Fluorescence Quantitative PCR System
Model / Reference
Q9600 Q1600
Primary DI / UDI-DI
06976014643011
Basic UDI-DI
697601464RFQPS012B
Direct Marketing DI
06976014643011
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000032705
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Chuangkun Biotech Inc.

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