Skip to content

Anti-CCP Control

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED

Ref 105-046688-00Model CL-series machine EMDN W0102152010

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB74000545T Basic UDI-DIDate6 Nov 2025RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Antibody to cyclic citrullinated peptides (CLIA)
Model / Reference
CL-series machine, 105-046688-00
Primary DI / UDI-DI
06903053077552
Basic UDI-DI
69449040AB74000545T
Unit of Use DI
06903053077583
EMDN Code
W0102152010 Controls for rheumatology
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 9aa59357-7651-402b-bab9-51f571942803 61 fields · synced 25 Oct 2026