PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 80943610088
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 80943610088 and manufactured by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. The registration is held by MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA. with validity until Jun 11, 2028.
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
Need help with your Brazil registration?
Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80943610088
25351348138202090
09058456000187
Company Information
Dates and Status
Jun 01, 2020
11/06/2028
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família AutoLumo Micropartículas de fPSA (CLIA)
Not specified
80102513409
Apr 22, 2025
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família AutoLumo Micropartículas de fPSA (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513409
Apr 22, 2025
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família AFIAS Free PSA
BODITECH MED INC.
10350840452
Mar 04, 2024
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família AFIAS Free PSA
Not specified
10350840452
Mar 04, 2024
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Maglumi PSA Livre (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512977
Mar 06, 2023
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