Número da Revisão
Rev.02
Data de Expiração
02/09/2027
Descrição
Scope: Design and development, manufacture and service of dental chairs, dental reflectors, dental water units, vacuum pumps, compressors, dental X-rays, dental equipment for prophylaxis, dental handpieces, photopolymerizer, dental radiographic imaging scanner, intraoral scanner, dental implant micromotor, dental autoclave, dental tips and software. Installation of dental chairs, dental reflectors, dental water units, vacuum pumps, compressors, dental X-rays and dental autoclave.
Norma
ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Japan: MHLW Ministerial Ordinance No.169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) Japan PMD Act (as applicable) 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