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Tuning solution for the analyte

EUDAMED

Class A (EU MDR)

Ref KM2000TURef KM1000TURef KM4000TU

by Immundiagnostik AG

Identity

Trade Name
Tuning solution for the analyte EUDAMED
Device Name
Accessories for Pregnolone sulfate LC-MS/MS EUDAMED
Accessories for 1,25-(OH)2-Vitamin D3/D2 LC-MS/MS product variants EUDAMED
Accessories for Hepcidin-25 LC-MS/MS EUDAMED
Model / Reference
KM2000TU EUDAMED
KM1000TU EUDAMED
KM4000TU EUDAMED

Identifiers

Primary DI / UDI-DI
04050598013810 EUDAMED
04050598011991 EUDAMED
04050598011946 EUDAMED
Basic UDI-DI
4050598LCACPhysiolLL EUDAMED
4050598LCACVITQV EUDAMED
4050598LCACFELX EUDAMED
Direct Marketing DI
04050598013810 EUDAMED
04050598011991 EUDAMED
04050598011946 EUDAMED
EMDN Code
W0102152208 STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS EUDAMED
W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMEDEUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMEDEUDAMED

Tuning solution for the analyte by Immundiagnostik AG — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Immundiagnostik AG
EUDAMED SRN
DE-MF-000020905

Sources (3)

  • EUDAMED e99aa91d-d6c5-471e-9a83-95311e6d3dcb 61 fields · synced Jul 15, 2026
  • EUDAMED 371e9ff0-d15b-452c-9fcc-c950aa0d9d2b 61 fields · synced May 17, 2026
  • EUDAMED 7599c697-04e4-4467-a95a-7a6b0acbb432 61 fields · synced May 19, 2026