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CHARMcm®

by biosurfit SA Portugal EUDAMED

Ref 910401Model CHARM Lp(a) control

EMDN W0102152004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number56006094490LP(a)CTRPA Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 827348 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    25 Sep 2026
    Expires
    24 Sep 2031

Specification

EUDAMED · synced 25 Oct 2026

Device Name
CHARM Lp(a) control
Model / Reference
CHARM Lp(a) control, 910401
Primary DI / UDI-DI
05600609449061
Basic UDI-DI
56006094490LP(a)CTRPA
EMDN Code
W0102152004 Cardiac marker controls
Device Class
Class B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
PT-MF-000033920

Other devices from biosurfit SA

See all devices from biosurfit SA →

Properties & raw data

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

Sources (1)

  • EUDAMED 05600609449061|56006094490LP(A)CTRPA 61 fields · synced 25 Oct 2026