ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 80416660119
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 80416660119 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The registration is held by SEBIA IMPORTAÇÕES COMERCIALIZAÇÃO E DISTRIBUIÇÃO DE APARELHOS E REATIVOS PARA DIAGNÓSTICO IN VITRO LTDA. with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
80416660119
25351607678202282
08576331000186
Company Information
Dates and Status
Jan 09, 2023
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
Anti-SS-A
ORGENTEC DIAGNOSTIKA GMBH
10300390521
May 20, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANTI-SSA
ORGENTEC DIAGNOSTIKA GMBH
10300390793
Jul 08, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
AESKULISA SS-A
AESKU DIAGNOSTICS
10259610182
Jul 10, 2017
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANTI-SSB
ORGENTEC DIAGNOSTIKA GMBH
10300390512
May 20, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
SS-A (RO)-EIA
HEMAGEN DIAGNOSTICS INC.
10322610042
Apr 08, 2019
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® Triagem de ENA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790434
Sep 16, 2024
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