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HPLC column

by Immundiagnostik AG

Ref KM4000SP

HPLC column (KM4000SP) is a Class A device made by Immundiagnostik AG, registered in EUDAMED on 27 May 2024 (Basic UDI-DI 4050598LCACFELX), active as of 22 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4050598LCACFELX Basic UDI-DI 04050598011960UDI-DIDate27 May 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Accessories for Hepcidin-25 LC-MS/MS
Model / reference
KM4000SP
Primary DI / UDI-DI
04050598011960
Basic UDI-DI
4050598LCACFELX
Direct marketing DI
04050598011960
EMDN code
W01019099 Clinical chemistry reagents - other
Device class
Class A
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000020905

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Similar devices in this category

Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

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Properties

  • Reagent
  • Professional testing
  • New device
Other properties (10, all answered No)