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OMNI® purification system sanguine - ARCSA Registration a5cfc1cfe70e60c3f1bd17fb7ae67985

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.

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ARCSA Official Data
III
a5cfc1cfe70e60c3f1bd17fb7ae67985
OMNI® purification system sanguine
ARCSA ID: a5cfc1cfe70e60c3f1bd17fb7ae67985
Local name: OMNI® sistema de depuración sanguínea
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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
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.

Manufacturer
Country
GERMANY
Address
AM BUSCHEBERG 1 34212 MELSUNGEN ALEMANIA
Product Owner
Name
B. BRAUN AVITUM AG
Country
GERMANY
Authorized Representative
Address
MANUEL AMBROSI E4-120 AND THE CYPRESSES
Phone
22611312