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Alt Ifcc Ifcc

by Fortress Diagnostics Ltd

Ref OLY0213AModel BXC0213D

Alt Ifcc Ifcc (OLY0213A) is a device classified as IVD General made by Fortress Diagnostics Ltd, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-05060476979144), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060476979144 Basic UDI-DI Date30 Oct 2026RegisteredStatusActive

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  • Withdrawn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

Device name
Alt (Gpt) (L.s) Ifcc
Model / reference
OLY0213A, BXC0213D
Primary DI / UDI-DI
05060476979144, 05060476971896
Basic UDI-DI
B-05060476979144, B-05060476971896
EMDN code
W01010103 Alanine amino-transferase
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000028408

Similar devices in this category

Other devices filed under ALANINE AMINO-TRANSFERASE.

Other devices from Fortress Diagnostics Ltd

See all devices from Fortress Diagnostics Ltd →

Properties

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