EUDAMED device

EZ Detect Colon Disease Test

EUDAMED device 00083059100013 · Biomerica, Inc.

Key facts

Primary DI 00083059100013
Trade name EZ Detect Colon Disease Test
Device name EZ Detect Colon Disease Test
Reference or catalog number 1000-1
Model 1000-1
Manufacturer Biomerica, Inc.
Manufacturer SRN US-MF-000015772
Risk class IVD devices for self-testing
EMDN code W0102039013
EMDN description FECAL OCCULT BLOOD (IC)
Legislation ivdd
Implantable No
Sterile No
Single use Yes
Status date Sep 24, 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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