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Boditech D-Dimer Calibrator

by Boditech Med Inc. South Korea EUDAMED

Ref CFPO-113Model Boditech D-Dimer Calibrator

EMDN W0103020799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08806133070062 Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Boditech D-Dimer Calibrator, CFPO-113
Primary DI / UDI-DI
08806133070062
Basic UDI-DI
B-08806133070062
EMDN Code
W0103020799 Haemostasis controls - other
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000011028
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 08806133070062|B-08806133070062 61 fields · synced 24 Oct 2026