PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10345162273
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 10345162273 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The registration is held by SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA with validity until May 21, 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, BECKMAN COULTER INC, 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
10345162273
25351000106201891
01449930000190
Company Information
Dates and Status
May 21, 2018
21/05/2028
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Atellica IM Antígeno Prostático Específico (PSA)
Not specified
10345162265
May 07, 2018
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Atellica IM Antígeno Prostático Específico (PSA)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162265
May 07, 2018
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Atellica IM Antígeno Prostático Específico Livre (fPSA)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162253
Apr 30, 2018
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Atellica IM Antígeno Prostático Específico Livre (fPSA)
Not specified
10345162253
Apr 30, 2018
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA IMC
BIOTECNICA INDUSTRIA E COMERCIO LTDA
80027310322
Feb 22, 2023
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
BECKMAN COULTER INC• United States of America
SIEMENS HEALTHCARE DIAGNOSTICS 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