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D-Dimer Assay Kit(Chemiluminescent Immunoassay)

by Chengdu Illumaxbio Technology Co., LTD EUDAMED

Active European Union

Ref C0122Model 48 strips/box

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06980222381221 Basic UDI-DIDate19 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
48 strips/box, C0122
Primary DI / UDI-DI
06980222381221
Basic UDI-DI
B-06980222381221
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000026407
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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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