Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

ALT / GPT (IFCC) — 2 UDI-DI variants, IVDR

MD Atlas
Thermo Fisher Scientific Oy

Data from EUDAMED, last updated May 23, 2026

ALT / GPT (IFCC)

6438153BU00157C3

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class B

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: Thermo Fisher Scientific Oy

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 6438153BU00157C3
Device name: ALT / GPT (IFCC)
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Nov 13, 2023

Manufacturer & authorised representative

Manufacturer

Name: Thermo Fisher Scientific Oy
SRN: FI-MF-000001479
Country: Finland
Email: registrations.clinical.fi@thermofisher.com
Phone: +358 10 329 200

Variants by status

UDI-DI variants

2 UDI-DI variants

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01HF3Y1GN171KBRMCJ9RG9M0TA

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

ALT / GPT (IFCC)16438153813610
ALT/GPT (IFCC)16438153817694