| NCC 25.11311 |
Rev.01 |
09/03/2028 |
Scope: Design, development, manufacture, distribution, sale and export of: Standard (non-customized) implantable medical devices, customized medical d...
Scope: Design, development, manufacture, distribution, sale and export of: Standard (non-customized) implantable medical devices, customized medical devices, sterile and non-sterile, in general, for craniomaxillofacial reconstruction, arthroplasty and fixation surgery; Customized “overdenture” devices for fixation of maxillary and mandibular prosthesis; Customized sterile and non-sterile instrumental devices for guiding the cutting, drilling and positioning of craniomaxillofacial implants; Standard (non- customized) non-sterile instrumental devices for guiding the cutting, drilling and positioning of temporomandibular joint implants; Sterile and non-sterile instrumental devices for craniomaxillofacial surgery; Customized silicone molds for manufacturing Polymethyl methacrylate (PMMA) implants; Orthopedic devices, including instruments and fixators.Import, distribution and sale of: electromedical equipment, including radiofrequency therapy equipment and its accessories; pulse lavage equipment for use in surgery; imaging equipment for intraoral scanning; in-vitro diagnostic products, including rapid test kits for qualitative detection of COVID 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 |
