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PCT Test Kit

by Yantai JIEZI Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref 10tests/kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978189070913 Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
PCT Test Kit
Model / Reference
10tests/kit
Primary DI / UDI-DI
06978189070913
Basic UDI-DI
B-06978189070913
EMDN Code
W0102160699 Rheumatoid / inflammatory disease rt & poc - other
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000044146
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Yantai JIEZI Biotechnology Co., Ltd.

See all devices from Yantai JIEZI Biotechnology Co., Ltd. →

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No