Certificados Emitidos MDSAP
| Nº. Certificado | Revisão | Validade | Descrição | Regulamento | Status |
| NCC 21.07037 | Rev. 00 | 17/08/2024 | Scope: Manufacture, Import, Export, Distribution, Design, Installation, Technical Assistance, Training and Rental of Electromedical and Medicalhospital devices in the Neurosurgery Area, including their Consumables (sterile and non-sterile) and the Development of Software related to the healthcare area. Not applicable items: Item 7.5.9.2 – Particular requirements for implantable healthcare products. | ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 | Ativo |
| NCC 22.09055 | Rev. 00 | 05/01/2025 | Scope: Design, development, manufacturing, sales, distribution, installation and technical assistance of dental office, clinical chairs and tables, reflectors and dental X-ray. Distribution of handpieces of high and low rotation, dental electrical, electronics and pneumatic motors, curing light, dental ultrasonic and compressors. Not applicable items: – 7.5.5: Particular requirements to sterile medical devices – 7.5.7:Particular requirements to process validation of sterilization and sterile barrier system – 7.5.9.2: Particular requirements to implantable medical devices |
ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 | Ativo |
| NCC 22.09095 | Rev. 00 | 07/02/2025 | Scope: Design, manufacturing, technical assistance and distribution of equipment of laser hair removal. Not applicable items:- 7.5.5: Particular requirements to sterile medical devices; – 7.5.7: Particular requirements to process validation of sterilization and sterile barrier system; – 7.5.9.2: Particular requirements to implantable. |
ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 | Ativo |
| NCC 22.07131 | Rev. 00 | 11/03/2025 | Scope:”Design, development, manufacturing, importing, salesandpost-marketing supporting of monitoring and diagnostic medical devices” Not applicable items: 7.5.3: Installation activities; 7.5.5: Particular requirements to sterile medical devices; 7.5.6: Validation of production processes and service provision; 7.5.7: Particular requirements to process validation of sterilization and sterile barrier system; 7.5.9.2 Particular requirements to implantable; 7.5.10: Customer property. |
ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 | Ativo |
| NCC22.09319 | REV.01 | 24/06/2025 | Scope:”Design,development, manufacture, sales and distribution of sterile and disposable instrument kits applicable to otolaryngology,orthopedics surgery and neurosurgery, equipos for ortopedics and sterile surgical electrodes for neurosurgery andortopedics“. Notapplicableitems:7.5.3: Installationactivities;7.5.4:Servicingactivities(Note:disposable products);7.5.9.2Particular requirements to implantable;7.5.10: Customer property. |
ISO 13485:2016 : RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021 ; RDC ANVISA nº67/2009 | Ativo |
| NCC 22.09287 | REV.01 | 17/06/2025 | Scope: “Design, development, manufacturing, sales, exportation and distribution of dental products, diamond burs, carbide Not applicable items: 7.5.3: Installation activities; 7.5.4: Servicing activities; 7.5.9.2: Particular requirements to implantable medical devices; 8.3.4: Rework. |
ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 551/ Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 EUA: 21 CFR 820 Japan: MHLW Ministerial Ordinance No.169 (2004) as amended by MHLW Ordinance No. 128 (2014) Articles 4 to 68; Japan PMD Act (as applicable) Canada: Medical Device Regulations SOR/98-282, Part 1 Australia: Schedule 3, Part 1 – Full Quality Assurance System; Schedule 3, Part 4 – Production Quality Assurance Procedures |
Ativo |
| NCC 22.09382 | REV.00 | 01/08/2025 | Scope: Design, manufacture, storage and distribution of hypothermic organ preservation solutions |
Notapplicableitems: 7.5.2-ProductCleaning 7.5.3-InstallationActivities 7.5.4-TechnicalAssistanceActivities 7.5.9.2-Particularrequirementsforimplantablemedicaldevices 7.5.10-Customerproperty 8.3.4–Rework |
ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 EUA : 21 CFR 820.20 Canadá: Medical DevicesRegulations–Part1-SOR 98/282 |
| xxxx | xxxx | xxxx | xxxx | xxxx | xxxx |
| xxxx | xxxx | xxxx | xxxx | xxxx | xxxx |
| xxxx | xxxx | xxxx | xxxx | xxxx | xxxx |
| xxxx | xxxx | xxxx | xxxx | xxxx | xxxx |