ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 80867150099
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 80867150099 and manufactured by SHENZHEN YHLO BIOTECH CO., LTD.. The registration is held by BIOMOLECULAR TECHNOLOGY COMÉRCIO, IMPORTAÇÃO, EXPORTAÇÃO E DISTRIBUIÇÃO DE MATERIAIS MÉDICOS E LABORATORIAIS LTDA - EPP 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
80867150099
25351662183202135
07767477000146
Company Information
Dates and Status
Jul 01, 2021
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
iFlash-SS-B IgG
SHENZHEN YHLO BIOTECH CO., LTD.
80867150098
Jul 01, 2021
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
iFlash-Sm IgG
SHENZHEN YHLO BIOTECH CO., LTD.
80867150101
Jul 01, 2021
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
iFlash-Scl-70 IgG
SHENZHEN YHLO BIOTECH CO., LTD.
80867150100
Jul 01, 2021
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
iFlash-RNP70 IgG
SHENZHEN YHLO BIOTECH CO., LTD.
80867150097
Jul 01, 2021
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
iFlash-Jo-1 IgG
SHENZHEN YHLO BIOTECH CO., LTD.
80867150096
Jul 01, 2021
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