Número da Revisão
Rev.02
Data de Expiração
09/03/2028
Descrição
Scope: “Design, development and manufacture of sterile and non-sterile implantable medical devices for craniomaxillofacial reconstruction, arthroplasty and fixation surgery; Overdenture devices for fixation of maxillary and mandibular prosthesis; Sterile and non-sterile instruments for guiding the cutting, drilling and positioning of craniomaxillofacial implants; guiding the cutting, drilling and positioning of temporomandibular joint implants; Craniomaxillofacial surgery; Customized silicone molds for manufacturing Polymethyl methacrylate (PMMA) implants; Orthopedic devices, including instruments and fixators. Distribution and service of radiofrequency therapy devices and its accessories; pulse lavage devices; imaging equipment for intraoral scanning. Distribution of in-vitro diagnostic products, including rapid test kits for qualitative detection of COVID, Dengue and Influenza.”
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009
Status
Ativo