ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 10338930057
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 10338930057 and manufactured by EUROIMMUN AG. The registration is held by EUROIMMUN BRASIL MEDICINA DIAGNOSTICA 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
10338930057
25351048819200864
93741726000166
Company Information
Dates and Status
Apr 22, 2008
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANTI-nRNP / Sm ELISA IgG EA 1591-9601 G
EUROIMMUN AG
10338930050
Mar 24, 2008
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANTI-SS-A ELISA IgG EA 1595-9601 G
EUROIMMUN AG
10338930047
Feb 25, 2008
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
SM-EIA
HEMAGEN DIAGNOSTICS, INC.
10322610039
Apr 08, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
SM/RNP-EIA
HEMAGEN DIAGNOSTICS INC.
10322610040
Apr 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
ANTI-SCL-70 ELISA IgG EA 1599-9601 G
EUROIMMUN AG
10338930051
Mar 24, 2008
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