PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80537410047
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 80537410047 and manufactured by GUANGZHOU WONDFO BIOTECH CO., LTD.. The registration is held by CELER BIOTECNOLOGIA S/A with validity until Feb 17, 2030.
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
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80537410047
25351028293202092
04846613000103
Company Information
Dates and Status
Feb 17, 2020
17/02/2030
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
CELER FINECARE PSA LIVRE TESTE QUANTITATIVO
Not specified
80537410075
Sep 21, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
CELER FINECARE PSA LIVRE TESTE QUANTITATIVO
GUANGZHOU WONDFO BIOTECH CO., LTD.
80537410075
Sep 21, 2020
PROSTATE-SPECIFIC ANTIGEN (PSA)
Celer One Step PSA Test (Imunocromatografia)
GUANGZHOU WONDFO BIOTECH CO., LTD.
80537410094
May 03, 2021
PROSTATE-SPECIFIC ANTIGEN (PSA)
Celer One Step PSA Test (Imunocromatografia)
Not specified
80537410094
May 03, 2021
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device (Sangue Total/Soro/Plasma)
ABON BIOPHARM (HANGZHOU) CO LTD
10071770842
Mar 30, 2015
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