PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10345161571
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 10345161571 and manufactured by manufacturer not specified. The registration is held by SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA with validity until Jun 22, 2034.
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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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
10345161571
25351127775200918
01449930000190
Company Information
Dates and Status
Sep 08, 2009
22/06/2034
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Calibrador fPSA
SIEMENS HEALTHCARE DIAGNIOSTICS INC.
10345161785
Dec 07, 2010
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Calibrador fPSA
Not specified
10345161785
Dec 07, 2010
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Calibrador Imunodiagnóstico Vitros* para PSA Livre
Not specified
81246986718
Aug 28, 2017
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Calibrador Imunodiagnóstico Vitros* para PSA Livre
ORTHO-CLINICAL DIAGNOSTICS
81246986718
Aug 28, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
Calibrador Imunodiagnóstico Vitros* para PSA Total II
ORTHO-CLINICAL DIAGNOSTICS
81246986719
Aug 28, 2017
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