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Reactive Protein Assay Kit (Fluorescence Immunochromatographic Assay Method)

by Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd. EUDAMED

Active European Union

Ref 1 test/box

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975808410310 Basic UDI-DIDate24 Sep 2024RegisteredStatusActive

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  • Withdrawn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
Reactive Protein Assay Kit (Fluorescence Immunochromatographic Assay Method)
Model / Reference
1 test/box
Primary DI / UDI-DI
06975808410310
Basic UDI-DI
B-06975808410310
EMDN Code
W0102160601 C-reactive protein - rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000044320
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.

Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No