PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10345160687
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 10345160687 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.. The registration is held by SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA with validity until Jun 02, 2033.
This page provides complete technical specifications for 2 related devices, 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
10345160687
25351019214200866
01449930000190
Company Information
Dates and Status
Jun 02, 2008
02/06/2033
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA IMMULITE 2000
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
10345160915
Sep 22, 2008
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA IMMULITE 2000
Not specified
10345160915
Sep 22, 2008
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA Livre IMMULITE/IMMULITE1000
Not specified
10345161013
Nov 24, 2008
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA Livre IMMULITE/IMMULITE1000
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
10345161013
Nov 24, 2008
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA Terceira Geração IMMULITE/ IMMULITE 1000
Not specified
10345160987
Nov 17, 2008
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
BECKMAN COULTER INC• United States of America
DIASORIN ITALIA S.P.A.• Italy
WAMA PRODUTOS PARA LABORATORIO LTDA• Brazil
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