PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80583710025
Access comprehensive regulatory information for PROSTATE-SPECIFIC ANTIGEN (PSA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80583710025 and manufactured by HI TECHNOLOGIES LTDA. The registration is held by HI TECHNOLOGIES LTDA with validity until Aug 22, 2032.
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including SIEMENS HEALTHCARE DIAGNOSTICS INC., ABBOTT IRELAND DIAGNOSTIC DIVISION, and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
80583710025
25351494997202211
07111023000112
Company Information
Dates and Status
Aug 22, 2022
22/08/2032
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA
IN VITRO DIAGNOSTICA LTDA
10303460530
Oct 03, 2022
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA IMC
BIOTECNICA INDUSTRIA E COMERCIO LTDA
80027310322
Feb 22, 2023
PROSTATE-SPECIFIC ANTIGEN (PSA)
UMELISA PSA
CENTRO DE INMUNOENSAYO
10188410027
Apr 03, 2006
PROSTATE-SPECIFIC ANTIGEN (PSA)
UMELISA PSA
Not specified
10188410027
Apr 03, 2006
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
VIDAS FPSA
Not specified
10158120355
Aug 27, 1999
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
BECKMAN COULTER INC• United States of America
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
DIASORIN ITALIA S.P.A.• Italy
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
FASTLINE FIA PSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220283
Jul 28, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
FIA PSA Total
GOLD ANALISA DIAGNOSTICA LTDA
80022230298
Jul 21, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
Not specified
80102513486
Jul 14, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513486
Jul 14, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família LIAISON® PSA II Gen
Not specified
10339840563
May 05, 2025