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Creatinine Ενζ

by Medicon Hellas SA

Ref 1516-0038

Creatinine Ενζ (1516-0038) is a Class C device made by Medicon Hellas SA, registered in EUDAMED on 22 Sep 2023 (Basic UDI-DI 5204309000017NT), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5204309000017NT Basic UDI-DI 05204309176533UDI-DIDate22 Sep 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Creatinine Enz
Model / reference
1516-0038
Primary DI / UDI-DI
05204309176533
Basic UDI-DI
5204309000017NT
EMDN code
W01010207 Creatinine
Device class
Class C
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 CREATININE.

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Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (10, all answered No)