EUDAMED device

Definium Tempo Select

EUDAMED device 00195278913814 · GE HUALUN MEDICAL SYSTEMS CO. Ltd

Key facts

Primary DI 00195278913814
Device name Definium Tempo Select
Reference or catalog number B2400UDI
Model Definium Tempo Select
Manufacturer GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN CN-MF-000001189
Risk class Class IIb
EMDN code Z11031101
EMDN description MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Sep 9, 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:

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