PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 10350840454
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 10350840454 and manufactured by BODITECH MED INC.. The registration is held by BIOSYS LTDA with validity until Mar 25, 2034.
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
10350840454
25351825614202342
02220795000179
Company Information
Dates and Status
Mar 25, 2024
25/03/2034
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
ichroma PSA Neo
BODITECH MED INC.
10350840281
Jan 18, 2016
PROSTATE-SPECIFIC ANTIGEN (PSA)
ichroma PSA Neo
Not specified
10350840281
Jan 18, 2016
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
fPSA Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010482
Oct 21, 2024
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
MAGLUMI™ f-PSA (CLIA)
Not specified
80102512160
Dec 10, 2018
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
MAGLUMI™ f-PSA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512160
Dec 10, 2018
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