Número da Revisão
Rev.00
Data de Expiração
02/10/2028
Descrição
Scope: Design, Development and Manufacture of sterile disposable flexible forceps, percutaneous feeding kit, replacement probes, instruments for extraction of intragastric balloons, valves for endoscopes, disposable papillotome, products for endoscopic resections, ENFit transition stepped adaptor. Non-sterile bite block, ligation system, exam pants, mechanical lithotriptor; and medical devices for endoscopy, gastrostomy and urology.
Norma
ISO 13485:2016 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 Medical Devices Regulations – Part 1.1 – SOR 98/282 (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