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Calcium

by Medicon Hellas SA

Ref 1415-0200, 1516-0200, 1418-0207, 1419-0201

Calcium (1415-0200) is an in vitro diagnostic device (EU IVDR Class B) made by Medicon Hellas SA, registered in EUDAMED on 28 Nov 2022 (Basic UDI-DI 5204309000012NH) and listed in FDA GUDID since 27 Apr 2026 (UDI-DI 05204309167371), 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 Number05204309167371 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number5204309000012NH Basic UDI-DI Date28 Nov 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5204309000012NH registered 28 Nov 2022 Active
  • FDA GUDID UDI-DI 05204309167371 listed 27 Apr 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 5204309000012NH
  2. Listed FDA GUDID 05204309167371

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  • Withdrawn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
Calcium (Ca2+) IVD, kit, spectrophotometry
Model / Ref / Catalog
1415-0200, 1516-0200, 1418-0207, 1419-0201
Primary DI / UDI-DI
05204309167371, 05204309175376, 05204309039883, 05204309115471
Basic UDI-DI
5204309000012NH
Direct marketing DI
05204309167371
05204309039883
05204309115471
EMDN code
W01010303 Calcium
GMDN term
Calcium (Ca2+) IVD, kit, spectrophotometry
Device class
Class B
EU registration type
Standard device
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
GR-MF-000013625

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Other devices filed under CALCIUM.

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Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)