Skip to content

hemochroma PLUS Control Set

by Boditech Med Inc. South Korea EUDAMED

Ref CFPO-29Model hemochroma PLUS Control Set

EMDN W0103010606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 053112 0038 Date21 Sep 2026IssuedStatusActive expires 20 Sep 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
hemochroma PLUS Control Set, CFPO-29
Primary DI / UDI-DI
08806133050026
Basic UDI-DI
880613306013CN
EMDN Code
W0103010606 Haematology controls - rt & poc
Device Class
Class B
Market of Registration
Germany

Manufacturer details

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

Other devices from Boditech Med Inc.

See all devices from Boditech Med Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 72f82fd3-9d14-4277-9d38-015d77e5012e 61 fields · synced 22 Oct 2026