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Lambda Free Light Chains Calibrator

by Medicon Hellas SA

Ref 1478-0665, 1418-0665

Lambda Free Light Chains Calibrator (1478-0665) is an in vitro diagnostic device (EU IVDR Class B) made by Medicon Hellas SA, registered in EUDAMED on 6 Mar 2026 (Basic UDI-DI 5204309000057P7), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5204309000057P7 Basic UDI-DI Date6 Mar 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Trade name
Lambda Free Light Chains Calibrator
Lambda Free Light Chains
Model / reference
1478-0665, 1418-0665
Primary DI / UDI-DI
05204309174898, 05204309174515
Basic UDI-DI
5204309000057P7
EMDN code
W0101050399, W0102010109
Device class
Class B
EU registration type
Standard device
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000013625

Similar devices in this category

Other devices filed under CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER.

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)