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Medi-Cal

by Medicon Hellas SA

Ref 1578-0891

Medi-Cal (1578-0891) is a Class C device made by Medicon Hellas SA, registered in EUDAMED on 22 Sep 2023 (Basic UDI-DI 5204309000051NT) and listed in FDA GUDID since 27 Apr 2026 (UDI-DI 05204309104789), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05204309104789 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number5204309000051NT Basic UDI-DI 05204309104789UDI-DIDate22 Sep 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5204309000051NT registered 22 Sep 2023 Active
  • FDA GUDID UDI-DI 05204309104789 listed 27 Apr 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 5204309000051NT
  2. Listed FDA GUDID 05204309104789

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Model / Ref / Catalog
1578-0891
Primary DI / UDI-DI
05204309104789
Basic UDI-DI
5204309000051NT
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device class
Class C
EU registration type
Standard device
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
GR-MF-000013625

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Medicon Hellas SA

See all devices from Medicon Hellas SA →

Properties

  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)