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Anti-CCP Control HumaFIA SR

by Beijing HumaDX Tech Co., Ltd. EUDAMED

Active European Union

Ref 16090/66Model 2 Levels × 0.3 mL + 1 × 1.0 mL Diluent

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976343800185 Basic UDI-DIDate11 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Anti-CCP Control HumaFIA SR
Model / Reference
2 Levels × 0.3 mL + 1 × 1.0 mL Diluent, 16090/66
Primary DI / UDI-DI
06976343800185
Basic UDI-DI
B-06976343800185
EMDN Code
W0102152011 Controls for autoimmunity
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000029051
Authorised representative
Human Gesellschaft für Biochemica und Diagnostica mbH DE-AR-000025586

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Properties

  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No