ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 81504790434
Access comprehensive regulatory information for ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 81504790434 and manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.. The registration is held by PASSROD IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS PARA SAÚDE LTDA - ME with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 companies making the same product including ORGENTEC DIAGNOSTIKA GMBH, SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD., 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.
Device Details
Registration Details
81504790434
25351383858202425
26185222000110
Company Information
Dates and Status
Sep 16, 2024
VIGENTE
09/18/2025 19:00:01
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI IgG anti-PM-Scl (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513501
Aug 11, 2025
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI IgG Anti-Ro-52 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513502
Aug 11, 2025
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Anti-Jo-1 IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790424
Aug 26, 2024
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Anti-SS-A/Ro IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790426
Aug 26, 2024
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Anti-SS-B IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790427
Aug 26, 2024

