PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 10287411525
Access comprehensive regulatory information for PROSTATE SPECIFIC ANTIGEN (PSA) FREE in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 10287411525 and manufactured by ROCHE DIAGNOSTICS GMBH. The registration is held by ROCHE DIAGNÓSTICA BRASIL LTDA with validity until Aug 17, 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 ABBOTT IRELAND DIAGNOSTIC DIVISION, DIASORIN ITALIA S.P.A., 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
10287411525
25351357997202070
30280358000186
Company Information
Dates and Status
Aug 17, 2020
17/08/2030
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Elecsys total PSA
ROCHE DIAGNOSTICS GMBH
10287411522
Aug 10, 2020
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Elecsys total PSA
Not specified
10287411522
Aug 10, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FAMÍLIA FPSA (CLIA)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
80943610088
Jun 01, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FAMÍLIA FPSA (CLIA)
Not specified
80943610088
Jun 01, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família AutoLumo Micropartículas de fPSA (CLIA)
Not specified
80102513409
Apr 22, 2025
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
DIASORIN ITALIA S.P.A.• Italy
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA• Brazil
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
FASTLINE FIA fPSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220286
Aug 18, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família AutoLumo Micropartículas de fPSA (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513409
Apr 22, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família AutoLumo Micropartículas de fPSA (CLIA)
Not specified
80102513409
Apr 22, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
fPSA Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010482
Oct 21, 2024
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família de Reagente, Calibradores e Controles Access Hybritech free PSA
Not specified
10033121064
May 28, 2024