PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 10345162253
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 10345162253 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The registration is held by SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA with validity until Apr 30, 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
10345162253
25351037426201805
01449930000190
Company Information
Dates and Status
Apr 30, 2018
30/04/2028
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Atellica IM Antígeno Prostático Específico (PSA)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162265
May 07, 2018
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 Específico de Próstata Complexado (cPSA)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162273
May 21, 2018
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família Atellica IM Antígeno Específico de Próstata Complexado (cPSA)
Not specified
10345162273
May 21, 2018
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Free Prostate Specific Antigen
WIENER LABORATORIOS S.A.I.C
10246810302
Dec 03, 2018
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
DIASORIN ITALIA S.P.A.• Italy
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA• Brazil
ORTHO-CLINICAL DIAGNOSTICS• United Kingdom
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