Número da Revisão
Rev.02
Data de Expiração
25/12/2027
Descrição
Scope: "Design, development, manufacture, installation and service of dental operative units, clinical chairs and powered tables, dental operating lights and dental X-rays. Distribution of electronic and pneumatic motors, curing lights, dental ultrasonic and compressors."
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.
Status
Ativo