PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10188410027
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 10188410027 and manufactured by manufacturer not specified. The registration is held by TECNOSUMA COMERCIO E INDUSTRIA DE KITS DIAGNOSTICOS E DE EQUIPAMENTOS MEDICOS LTDA with validity until Apr 03, 2026.
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
10188410027
25351053250200697
64779853000156
Company Information
Dates and Status
Apr 03, 2006
03/04/2026
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
BIOLISA PSA TOTAL
QUIBASA QUÍMICA BÁSICA LTDA
10269360364
Aug 15, 2022
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA
IN VITRO DIAGNOSTICA LTDA
10303460530
Oct 03, 2022
PROSTATE-SPECIFIC ANTIGEN (PSA)
HUMASIS PSA CARD
HUMASIS CO., LTDA
80615950228
Jul 15, 2019
PROSTATE-SPECIFIC ANTIGEN (PSA)
HUMASIS PSA CARD
Not specified
80615950228
Jul 15, 2019
PROSTATE-SPECIFIC ANTIGEN (PSA)
Ultra Sensitive Total Prostate Specific Antigen (PSA XS) Test System - ELISA
MONOBIND, INC
80048490095
Sep 15, 2014
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