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Ammonia

by Medicon Hellas SA 2 variants

Ref 1415-1042

Ammonia (1415-1042) is a device classified as IVD General made by Medicon Hellas SA, registered in EUDAMED on 11 Dec 2023 (Basic UDI-DI B-05204309167234), active as of 23 Oct 2026.

Active European Union

CE IVDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05204309167234 Basic UDI-DI 05204309167234UDI-DIDate11 Dec 2023RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / reference
1415-1042
Primary DI / UDI-DI
05204309167234
Basic UDI-DI
B-05204309167234
EMDN code
W01010301 Ammonia
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000013625

Similar devices in this category

Other devices filed under AMMONIA.

Other devices from Medicon Hellas SA

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Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)