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D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

by Shenzhen Microprofit Biotech Co., Ltd EUDAMED

Active European Union

Ref MF-34-20Model 20 Tests/Box

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971348760380 Basic UDI-DIDate23 Jul 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  • Withdrawn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
20 Tests/Box, MF-34-20
Primary DI / UDI-DI
06971348760380
Basic UDI-DI
B-06971348760380
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000019518
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen Microprofit Biotech 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