EUDAMED device

SIGNA 7.0T

EUDAMED device 00195278483713 · GE Medical Systems LLC

Key facts

Primary DI 00195278483713
Trade name SIGNA 7.0T
Device name SIGNA 7.0T
Reference or catalog number SIGNA 7.0T
Model SIGNA 7.0T
Manufacturer GE Medical Systems LLC
Manufacturer SRN US-MF-000001632
Risk class Class IIa
EMDN code Z11050106
EMDN description CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 4T
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Oct 30, 2025

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:

Browse all EUDAMED devices