EUDAMED device

Mac-Lab AltiX

EUDAMED device 00195278507037 · GE Medical Systems Information Technologies, Inc.

Key facts

Primary DI 00195278507037
Trade name Mac-Lab AltiX
Device name Mac-Lab
Reference or catalog number 2300000-003
Model AltiX
Manufacturer GE Medical Systems Information Technologies, Inc.
Manufacturer SRN US-MF-000017529
Risk class Class IIa
EMDN code Z12050702
EMDN description POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Aug 31, 2022

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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