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Tuning solution for the internal standard

by Immundiagnostik AG Germany EUDAMED

Ref KM2000TS

EMDN W0102152208

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4050598LCACPhysiolLL Basic UDI-DIDate28 Oct 2024RegisteredStatusActive

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
Accessories for Pregnolone sulfate LC-MS/MS
Model / Reference
KM2000TS
Primary DI / UDI-DI
04050598013827
Basic UDI-DI
4050598LCACPhysiolLL
Direct Marketing DI
04050598013827
EMDN Code
W0102152208 Standards and calibrators for individual and specific hormones /proteins
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000020905

Other devices from Immundiagnostik AG

See all devices from Immundiagnostik AG →

Properties & raw data

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

Sources (1)

  • EUDAMED 018b3b9b-b27b-4dea-9c9d-72cba067a764 61 fields · synced 22 Oct 2026