Skip to content

Rheumatoid Factor/Anti-Cyclic Citrullinated Peptide Antibody/Antistreptolysin O Test Kit (QDs-FICA)

by Chongqing Juce Life Health Technology Co., Ltd. EUDAMED

Active European Union

Ref CA1301Model 1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box and 100 pcs/box

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977981880140 Basic UDI-DIDate20 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  • Withdrawn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

Model / Reference
1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box and 100 pcs/box, CA1301
Primary DI / UDI-DI
06977981880140
Basic UDI-DI
B-06977981880140
EMDN Code
W0105070599 Multiple infectious - multiplex assays - other
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000053774
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Chongqing Juce Life Health Technology Co., Ltd.

See all devices from Chongqing Juce Life Health Technology Co., Ltd. →

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