EUDAMED device

MyoSPECT

EUDAMED device 00195278488619 · GE Medical Systems Israel", Functional Imaging

Key facts

Primary DI 00195278488619
Trade name MyoSPECT
Device name MyoSPECT
Reference or catalog number H3912BC
Model MyoSPECT
Manufacturer GE Medical Systems Israel", Functional Imaging
Manufacturer SRN IL-MF-000003062
Risk class Class IIa
EMDN code Z11020104
EMDN description FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Oct 15, 2023

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)

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