EUDAMED device

OMA (810 nm)

EUDAMED device 00813125010591 · Iridex Corporation

Key facts

Primary DI 00813125010591
Trade name OMA (810 nm)
Device name Operating Microscope Adapter (OMA)
Reference or catalog number 11671
Manufacturer Iridex Corporation
Manufacturer SRN US-MF-000029814
Risk class Class I
EMDN code Z12120199
EMDN description OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - OTHER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Jan 14, 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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