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a-AMYLASE

by Medicon Hellas SA 3 variants

Ref 1517-0160

a-AMYLASE (1517-0160) is a Class C device made by Medicon Hellas SA, registered in EUDAMED on 30 Dec 2022 (Basic UDI-DI 5204309000001NC), 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 Number5204309000001NC Basic UDI-DI 05204309175550UDI-DIDate30 Dec 2022RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
1517-0160
Primary DI / UDI-DI
05204309175550
Basic UDI-DI
5204309000001NC
EMDN code
W01010107 Amylase - total
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 AMYLASE - TOTAL.

Other devices from Medicon Hellas SA

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Properties

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