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mAbXmise OTDM1

by Promise proteomics France EUDAMED

Ref OTDM1 EMDN W0102080704,W01020899

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03770024131024 Basic UDI-DIDate8 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
mAbXmise – Monoclonal antibodies quantification Kit Multiplex Nivolumab, Pembrolizumab, Trastuzumab, Cetuximab, Bevacizumab, Ipilimumab, Rituximab
Model / Reference
OTDM1
Primary DI / UDI-DI
03770024131024
Basic UDI-DI
B-03770024131024
EMDN Code
W0102080704,W01020899
Device Class
Class IVD General
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
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 86efc17f-fd56-4d84-b093-b7896852647d 61 fields · synced 24 Oct 2026