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mAbXmise PNHTDM

by Promise proteomics France EUDAMED

Ref PNHTDM

EMDN W01020899

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770024131PNH-TDM7A Basic UDI-DIDate24 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
mAbXmise – Monoclonal antibodies quantification Kit Eculizumab or Ravulizumab
Model / Reference
PNHTDM
Primary DI / UDI-DI
03770024131055
Basic UDI-DI
3770024131PNH-TDM7A
Direct Marketing DI
03770024131055
EMDN Code
W01020899 Therapeutic drug monitoring - other
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000027377

Other devices from Promise proteomics

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c7415731-e62f-41fb-9f98-09af3ee85762 61 fields · synced 22 Oct 2026