| NCC 25.11311 |
Rev.02 |
09/03/2028 |
Scope: “Design, development and manufacture of sterile and non-sterile implantable medical devices for craniomaxillofacial reconstruction, arthroplast...
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.”
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ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009
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Ativo |
