EUDAMED device

EZ-PSA Professional PSA Test

EUDAMED device 00083059108156 · Biomerica, Inc.

Key facts

Primary DI 00083059108156
Trade name EZ-PSA Professional PSA Test
Device name EZ-PSA Professional PSA Test
Reference or catalog number 1081-15
Model 1081-15
Manufacturer Biomerica, Inc.
Manufacturer SRN US-MF-000015772
Risk class IVD Annex II List B
EMDN code W0102160202
EMDN description PSA - RT & POC
Legislation ivdd
Implantable No
Sterile No
Single use No
Status date Sep 24, 2024

At a glance

  • No 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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