EUDAMED device

intelliMammo® densityAI™

EUDAMED device 00628678950047 · Densitas Inc

Key facts

Primary DI 00628678950047
Trade name intelliMammo® densityAI™
Device name intelliMammo® densityAI™
Reference or catalog number 2.x.y
Model 2.x.y
Manufacturer Densitas Inc
Manufacturer SRN CA-MF-000008573
Risk class Class I
EMDN code Z11030282
EMDN description MAMMOGRAPHY SYSTEMS - SOFTWARE ACCESSORIES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Sep 6, 2024

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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