PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10287411522
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 10287411522 and manufactured by manufacturer not specified. The registration is held by ROCHE DIAGNÓSTICA BRASIL LTDA with validity until Aug 10, 2030.
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
10287411522
25351292806202017
30280358000186
Company Information
Dates and Status
Aug 10, 2020
10/08/2030
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Elecsys free PSA
ROCHE DIAGNOSTICS GMBH
10287411525
Aug 17, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Elecsys free PSA
Not specified
10287411525
Aug 17, 2020
PROSTATE-SPECIFIC ANTIGEN (PSA)
Elecsys Total PSA
ROCHE DIAGNOSTICS GMBH
10287411221
May 02, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
Elecsys Total PSA
Not specified
10287411221
May 02, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Maglumi PSA Total (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512976
Mar 06, 2023
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