EUDAMED device

Aware Breast Self Exam

EUDAMED device 00083059012033 · Biomerica, Inc.

Key facts

Primary DI 00083059012033
Trade name Aware Breast Self Exam
Device name AWARE Breast Self Exam Pad
Reference or catalog number 1203
Model 1203
Manufacturer Biomerica, Inc.
Manufacturer SRN US-MF-000015772
Risk class Class I
EMDN code V9099
EMDN description DISPOSITIVI VARI NON COMPRESI IN ALTRE CLASSI - ALTRI|DIVERS DISPOSITIFS MÉDICAUX NON COMPRIS DANS UNE AUTRE CATÉGORIE - AUTRES|VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Feb 28, 2022

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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