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D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)

by Dirui Industrial Co., Ltd EUDAMED

Active European Union

Ref 3021633Model R1: 1x25mL, R2: 1x25mL,Diluent：1x55mL, Calibrator: 6x0.5mL, Control:Low value:1x0.5mL High value: 1x0.5mL

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06925794591944 Basic UDI-DIDate15 Apr 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  • Withdrawn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
R1: 1x25mL, R2: 1x25mL, Diluent：1x55mL, Calibrator: 6x0.5mL, Control:Low value:1x0.5mL High value: 1x0.5mL, 3021633
Primary DI / UDI-DI
06925794591944
Basic UDI-DI
B-06925794591944
EMDN Code
W0102019099 Specific proteins - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001891
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No