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D-Dimer (D-D) Assay Kit (Chemiluminescent Immunoassay)

by Sichuan Orienter Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref DG0501Model 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06942028501647 Basic UDI-DIDate19 May 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  • Withdrawn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
2×50 tests/box Calibrator: 0.5mL×2, Quality control: 1.0mL×2, DG0501
Primary DI / UDI-DI
06942028501647
Basic UDI-DI
B-06942028501647
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003026
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Sichuan Orienter Biotechnology Co., Ltd.

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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