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alpha-AMYLASE - DIRECT

by Biosystems S.A. 5 variants

Ref 12550

alpha-AMYLASE - DIRECT (12550) is an in vitro diagnostic device (EU IVDR Class C; EMDN category amylase isoenzymes) made by Biosystems S.A., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 8435287110AMYDIR00004D), 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 Number8435287110AMYDIR00004D Basic UDI-DI 08435287125504UDI-DIDate27 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
alpha-AMYLASE - DIRECT
Model / reference
12550
Primary DI / UDI-DI
08435287125504
Basic UDI-DI
8435287110AMYDIR00004D
EMDN code
W01010108 Amylase isoenzymes
Device class
Class C
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000231

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Properties

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