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D-Dimer/FDP Controls

by Medcaptain Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref MCC00901E

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06926802608937 Basic UDI-DIDate30 Sep 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  • Withdrawn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

Device Name
D-Dimer/FDP Controls
Model / Reference
MCC00901E
Primary DI / UDI-DI
06926802608937
Basic UDI-DI
B-06926802608937
EMDN Code
W0103020799 Haemostasis controls - other
Device Class
Class IVD General
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000005925
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Medcaptain Medical Technology Co., Ltd.

See all devices from Medcaptain Medical Technology Co., Ltd. →

Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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