PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10345161115
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 10345161115 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC. The registration is held by SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA with validity until Jun 22, 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 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
Need help with your Brazil registration?
Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
10345161115
25351127753200926
01449930000190
Company Information
Dates and Status
Jul 27, 2009
22/06/2034
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
CARTUCHO DE REAGENTE FLEX PARA PSA LIVRE (FPSA) DIMENSION
SIEMENS HEALTHCARE DIAGNOSTICS INC
10345161193
Aug 10, 2009
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
CARTUCHO DE REAGENTE FLEX PARA PSA LIVRE (FPSA) DIMENSION
Not specified
10345161193
Aug 10, 2009
PROSTATE-SPECIFIC ANTIGEN (PSA)
CALIBRADOR DE PSA TOTAL E LIVRE DIMENSION
Not specified
10345161571
Sep 08, 2009
PROSTATE-SPECIFIC ANTIGEN (PSA)
CALIBRADOR DE PSA TOTAL E LIVRE DIMENSION
SIEMENS HEALTHCARE DIAGNOSTICS INC
10345161571
Sep 08, 2009
PROSTATE-SPECIFIC ANTIGEN (PSA)
Kit de Teste Rápido Antígeno Prostático Específico (PSA) (Teste Imunocromatográfico por Fluorescência)
Not specified
82444370101
Apr 15, 2024
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