PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80721060029
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 80721060029 and manufactured by manufacturer not specified. The registration is held by JC Pharma & Health Comércio, Exportação e Importação Ltda with validity until Sep 21, 2025.
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
80721060029
25351319090201522
01662176000171
Company Information
Dates and Status
Sep 21, 2015
21/09/2025
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole Blood/Serum/Plasma)
ZHEJIANG ORIENT GENE BIOTECH CO., LTD.
82444370175
Jan 27, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole Blood/Serum/Plasma)
Not specified
82444370175
Jan 27, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA RAPID TEST
DIAGNÓSTICA INDÚSTRIA E COMÉRCIO LTDA - ME
80638720171
Feb 08, 2021
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA RAPID TEST
DIAGNÓSTICA INDÚSTRIA E COMÉRCIO LTDA - ME
80638720091
Jul 30, 2018
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TEST CASSETE FIA
Not specified
80638720188
Jul 12, 2021
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