Número da Revisão
Rev.03
Data de Expiração
29/12/2026
Descrição
Scope: Design, manufacture, distribution, sales and technical assistance services of medical devices for cryolipolysis, radiofrequency, ultrasound, electromagnetic stimulation, laser equipment, air abrasion aesthetics system, therapeutic massager, cooling device for dermatological treatments and camera for capturing images of the skin for dermatology.
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 / RDC ANVISA nº 551/2021 / RDC ANVISA nº 67/2009 USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation 21 CFR Part 821 - Device Tracking
Status
Ativo