PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10350840436
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 10350840436 and manufactured by BODITECH MED INC.. The registration is held by BIOSYS LTDA with validity until May 15, 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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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
10350840436
25351090736202315
02220795000179
Company Information
Dates and Status
May 15, 2023
15/05/2033
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família AFIAS Free PSA
Not specified
10350840452
Mar 04, 2024
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família AFIAS Free PSA
BODITECH MED INC.
10350840452
Mar 04, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Total Prostate Specific Antigen
Not specified
10246810300
Dec 03, 2018
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Total Prostate Specific Antigen
WIENER LABORATORIOS S.A.I.C
10246810300
Dec 03, 2018
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Free Prostate Specific Antigen
Not specified
10246810302
Dec 03, 2018
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