Número da Revisão
Rev.04
Data de Expiração
27/04/2026
Descrição
Scope: Scope: “Design, manufacturing, sales and distribution of medical and dental products: metallic
componentes – Dentfix, surgical instruments, no-articulated sharp instruments to micro and mini fragments,
no-articulated sharp instruments, Diamond burs – Medicalfix, instruments – Medicalfix, articulated no-sharp
instruments – Medicalfix, Diamond ultrasound tips, plate base, surgical kit – Dentfix, metallic components to
implants – Dentfix, prosthetic components in polymers, surgical blades – Medicalfix, healer – Dentfix,
ultrasound tips with TIN recovering – Medicalfix, polymeric components to implants – Dentfix, dental implants
with superficial treatment, orthodontic screws, micro and mini fragments straight plate – Medicalfix, micro and
mini fragments screws – Medicalfix, Titanium components – Dentfix, locking rigid fixation system – Medicalfix
and Medicalfix 2.4, cranial closure system – Medicalfix, templates – Medicalfix, palatal distractor – Traumafix,
micro and mini fragments special plates – Medicalfix.”
componentes – Dentfix, surgical instruments, no-articulated sharp instruments to micro and mini fragments,
no-articulated sharp instruments, Diamond burs – Medicalfix, instruments – Medicalfix, articulated no-sharp
instruments – Medicalfix, Diamond ultrasound tips, plate base, surgical kit – Dentfix, metallic components to
implants – Dentfix, prosthetic components in polymers, surgical blades – Medicalfix, healer – Dentfix,
ultrasound tips with TIN recovering – Medicalfix, polymeric components to implants – Dentfix, dental implants
with superficial treatment, orthodontic screws, micro and mini fragments straight plate – Medicalfix, micro and
mini fragments screws – Medicalfix, Titanium components – Dentfix, locking rigid fixation system – Medicalfix
and Medicalfix 2.4, cranial closure system – Medicalfix, templates – Medicalfix, palatal distractor – Traumafix,
micro and mini fragments special plates – Medicalfix.”
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Status
Ativo