EUDAMED device

Helion

EUDAMED device 00615521031886 · Videomed Srl

Key facts

Primary DI 00615521031886
Trade name Helion
Reference or catalog number CM401326
Model 116001
Manufacturer Videomed Srl
Manufacturer SRN IT-MF-000024944
Risk class Class I
EMDN code Z11069082
EMDN description VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Feb 9, 2026

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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