PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 82444370101
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 82444370101 and manufactured by GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.. The registration is held by Enzytec Biotecnologia Ltda. with validity until Apr 15, 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
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
82444370101
25351910148202481
07214566000165
Company Information
Dates and Status
Apr 15, 2024
15/04/2034
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Teste Rápido PSA
GUANGZHOU WONDFO BIOTECH CO. LTD
82533950052
Feb 26, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
Teste rápido PSA
Not specified
81472060041
Apr 28, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
Teste rápido PSA
HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.
81472060041
Apr 28, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
Teste Rápido PSA
Not specified
82533950052
Feb 26, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
Teste Rápido Onsite PSA Semi-Quantitativo
Not specified
80524900045
Oct 17, 2016
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