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D-Dimer Assay Kit (Immunoturbidimetry Method)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. EUDAMED 2 variants

Active European Union

Ref 105-023628-00, 105-023629-00, 105-023630-00Model 105-023628-00、105-023629-00、105-023630-00、105-023647-00、105-024608-00、105-024609-00、105-024610-00

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB75000025M Basic UDI-DIDate27 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
D-Dimer Assay Kit (Immunoturbidimetry Method)、D-Dimer Calibrators、D-Dimer Control
Model / Reference
105-023628-00、105-023629-00、105-023630-00、105-023647-00、105-024608-00、105-024609-00、105-024610-00, 105-023628-00, 105-023629-00, 105-023630-00
Primary DI / UDI-DI
06903053025461, 06903053025478, 06903053025485
Basic UDI-DI
69449040AB75000025M
EMDN Code
W0103020503 D-dimer
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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