RESOLUÇÃO RE Nº 842, DE 24 DE Fevereiro DE 2021
| Páginas | 142-142 |
| Data de publicação | 01 Março 2021 |
| Data | 24 Fevereiro 2021 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,4ª Diretoria,Gerência-Geral de Inspeção e Fiscalização Sanitária |
| Seção | DO1 |
RESOLUÇÃO RE Nº 842, DE 24 DE Fevereiro DE 2021
A Gerente-Geral de Inspeção e Fiscalização Sanitária, no uso das atribuições que lhe confere o art. 171, aliado ao art. 54, I, § 1º do Regimento Interno aprovado pela Resolução de Diretoria Colegiada - RDC nº 255, de 10 de dezembro de 2018, considerando o cumprimento dos requisitos dispostos no art. 8º, da Resolução de Diretoria Colegiada - RDC nº 183, de 17 de outubro de 2017, resolve:
Art. 1º Conceder às empresas constantes no anexo a Certificação de Boas Práticas de Fabricação de Produtos para Saúde.
Art. 2º A presente certificação terá validade de 2 (dois) anos a partir de sua publicação.
Art. 3º Esta Resolução entra em vigor na data de sua publicação.
ANA CAROLINA MOREIRA MARINO ARAUJO
ANEXO
Fabricante: Hibergene Diagnostics
Endereço: Block 2, Bracken Business Park, Sandyford - Dublin, D18 - Irlanda
Solicitante: Biomédica Equpamentos e Suprimentos Hospitalares Ltda. CNPJ: 01299509/0001-40
Autorização de Funcionamento: 1035587 Expediente: 0249362/18-4
Certificado de Boas Práticas de Fabricação de Produtos para Saúde.
Produtos para diagnóstico de uso in vitro da classe III.
----------------------------------------------------------------------------------
Fabricante: Invatec S.p.A.
Endereço: Via Industria, 26/28, Torbole Casaglia, Brescia., 25030 - Itália
Solicitante: Auto Suture do Brasil Ltda. CNPJ: 01.645.409/0001-28
Autorização de Funcionamento: 1.03.490-0 Expediente: 3416103/20-3
Certificado de Boas Práticas de Fabricação de Produtos para Saúde.
Materiais de uso médico da classe IV.
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