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Alt/Gpt

by Giesse Diagnostics SRL 2 variants

Ref BT4193, 4193, 4194/50

Alt/Gpt (BT4193) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category alanine amino-transferase) made by Giesse Diagnostics SRL, registered in EUDAMED on 20 Feb 2026 (Basic UDI-DI B-08053172972905), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08053172972905 Basic UDI-DI Date20 Feb 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  • Withdrawn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 - Biotecnica Systems
Model / reference
BT4193, 4193, 4194/50
Primary DI / UDI-DI
08053172972905, 08053172970116, 08053172970109
Basic UDI-DI
B-08053172972905, B-08053172970116, B-08053172970109
EMDN code
W01010103 Alanine amino-transferase
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000039031

Related devices

Category: Alanine aminotransferase (ALT) IVD, reagent

Similar devices in this category

Other devices filed under ALANINE AMINO-TRANSFERASE.

Other devices from Giesse Diagnostics SRL

See all devices from Giesse Diagnostics SRL →

Properties

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