EUDAMED device

Diagnostix™

EUDAMED device 00634782087425 · American Diagnostic Corporation

Key facts

Primary DI 00634782087425
Trade name Diagnostix™
Device name Opthalmoscope and parts
Reference or catalog number 5480X
Manufacturer American Diagnostic Corporation
Manufacturer SRN US-MF-000021544
Risk class Class I
EMDN code Z12040102,Z12120114,Z12149006
EMDN description DIRECT OUTPATIENT OTOSCOPES|EQUIPMENT FOR ANALYSIS OF THE PHYSIOLOGICAL PARAMETERS OF THE SKIN|OPHTHALMOSCOPES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Apr 28, 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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