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Diagnostic Kit for D-Dimer (Immunochromatographic assay)

by WWHS Biotech.Inc EUDAMED

Active European Union

Ref CP004.B2Model 20Tests/Kit

Overview

A comprehensive Diagnostic Kit for D-Dimer (Immunochromatographic assay) designed to accurately detect D-dimer levels in patients, enabling early diagnosis and treatment. The device features a self-testing capability of 0, making it ideal for use in various settings.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975068491289 Basic UDI-DIDate4 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
20Tests/Kit, CP004.B2
Primary DI / UDI-DI
06975068491289
Basic UDI-DI
B-06975068491289
EMDN Code
W0103020803 D-dimer - rt & poc
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000027179
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

Show properties
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Companion Diagnostics
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No