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ANVISA registration 80416660257Active

ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)

ANVISA Registration Number: 80416660257SEBIA IMPORTAÇÕES COMERCIALIZAÇÃO E DISTRIBUIÇÃO DE APARELHOS E REATIVOS PARA DIAGNÓSTICO IN VITRO LTDA.ORGENTEC DIAGNOSTIKA GMBHRisk Class II
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Device names
Technical name
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
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PT: ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Commercial name
Anti-SS-A 52
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Risk class
Class II
Registration details
Registration Number
80416660257
Process Number
25351107437202661
CNPJ
08576331000186
Company information
Registration Holder
SEBIA IMPORTAÇÕES COMERCIALIZAÇÃO E DISTRIBUIÇÃO DE APARELHOS E REATIVOS PARA DIAGNÓSTICO IN VITRO LTDA.
Manufacturer
ORGENTEC DIAGNOSTIKA GMBH
Manufacturing Country
Germany
PT: ALEMANHA
Dates and status
Publication Date
Jul 06, 2026
Validity
VIGENTE
Last Updated
08/18/2026 19:00:00
About this record

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 80416660257 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 shows the facts attached to this official registry row. Exact-name links return deterministic registry matches; open-ended comparison and market analysis are handed to AI Search with this record's context, without asserting that similar names represent the same entity.