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Anti-Cyclic Citrullinated Peptide Antibody Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit

EMDN W01021112

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719607341 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Anti-Cyclic Citrullinated Peptide Antibody Chemiluminescence Immunoassay Kit
Model / Reference
Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit, 50tests/kit
Primary DI / UDI-DI
06972719607341
Basic UDI-DI
B-06972719607341
EMDN Code
W01021112 Anti-cyclic citrullinated peptide
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 6304722e-02ef-49ae-b8b4-63fc0aaae8f3 61 fields · synced 24 Oct 2026