a5cfc1cfe70e60c3f1bd17fb7ae67985

OMNI® purification system sanguine

Local name: OMNI® sistema de depuración sanguínea

B. BRAUN AVITUM AG·III·Ecuador ARCSA·Registered December 29, 2022

Device classification

Risk class: III
Product type: Active
Brand name: OMNI®
Commercial name: Hemodialysis Units

Registration information

Analysis ID: a5cfc1cfe70e60c3f1bd17fb7ae67985
Registration date: December 29, 2022
Expiration date: December 29, 2027

Manufacturer

Name: B. BRAUN AVITUM AG
Country: GERMANY
Address: AM BUSCHEBERG 1 34212 MELSUNGEN ALEMANIA

Product owner

Name: B. BRAUN AVITUM AG
Country: GERMANY

Authorized representative

Name: B.BRAUN MEDICAL S.A.
Address: MANUEL AMBROSI E4-120 AND THE CYPRESSES
Phone: 22611312

Product use

OMNI IS USED TO PERFORM TREATMENTS CONTINUOUS BLOOD PURIFICATION, HEMODIALYSIS THERAPIES, THERAPEUTIC PLASMA EXCHANGE WITH EXTRACTION OF PLASMA COMPONENTS. OMNI IS USED IN PATIENTS WITH ACUTE RENAL FAILURE AND/OR FLUID OVERLOAD, AND/OR POISONING, WHO REQUIRE CONTINUOUS BLOOD PURIFICATION TREATMENTS. FOR THERAPEUTIC PLASMA EXCHANGE (TPE) TREATMENTS IN PATIENTS WITH VARIOUS DISEASES WHERE EPT HAS BEEN PRESCRIBED.

About this record

Access comprehensive regulatory information for OMNI® purification system sanguine in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID a5cfc1cfe70e60c3f1bd17fb7ae67985 and manufactured by B. BRAUN AVITUM AG. The device was registered on December 29, 2022.

This page provides complete registration details including product type (Active), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.