Certificados Emitidos MDSAP
| Nº. Certificado | Revisão | Validade | Descrição | Regulamento | Status |
| NCC 21.07037 | Rev. 01 | 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. 01 | 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.01 | 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 22.09319 | 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.02 | 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 22.09554 | REV.02 | 06/10/2025 | Scope: Desing, Development and Production of medical devices for endoscopy, gastronomy and urology. | ISO 13485:2016 Not applicable items: Item 7.5.3 – Installation Activities Item 7.5.4 – Technical Assistance Activities 7.5.10 – Customer Property | Ativo |
| NCC 22.09498 | REV.00 | 13/09/2025 | Scope: Design, Development, Manufacture and Distribution of CranioMaxilloFacial Orthopedic Implants, Spine, Extremities (hand and foot), thoracic and Surgical Instruments. Distribution and Technical Assistance of Piezoelectric Motor. | ISO 13485:2016 Not applicable items: Item 7.5.3 – Installation Activities | Ativo |
| NCC 22.09627 | REV.00 | 04/11/2025 | Scope: “Design, Manufacture, Sale and Distribution of Surgical Instruments, External Fixators, Consumable Materials and non-active sterile and non-sterile Implantable Products for: hip, knee and shoulder arthroplasty, craniomaxillofacial osteosynthesis, extremities and traumatology, spine and sports medicine.” | ISO 13485:2016 Not applicable items: Item 7.5.3 – Installation Activities | Ativo |
| NCC 22.09723 | REV.00 | 16/12/2025 | Scope: Design, development, manufacturing, distribution, marketing and after-sales support of medical devices, specifically defibrillators/cardioverters and multiparameter monitors. | ISO 13485:2016; Not applicable items: 7.5.3 – Installation activities. 7.5.5 – Particular requirements for sterile health products. 7.5.7 – Particular requirements for validation of sterilization processes and sterile barrier systems. 7.5.10 – Customer property. 7.5.9.2 – Particular requirements for implantable medical devices. | Ativo |
| NCC 23.09766 | REV.00 | 06/01/2026 | Scope: Design, Development, Production, and Service of Silicone Gel Filled Breast Implants, Silicone Facial Subcutaneous Implants, Tissue Expander for Single Use, Medical Silicone Gel Sheet, Nostril Retaine. | ISO 13485:2016; Not applicable items: 7.5.3 Installation activities 7.5.4 Servicing activities | Ativo |
| NCC 22.09740 | REV.01 | 26/12/2025 | Scope: Design, development, manufacturing, exportation and distribution of 0.9% Sodium Chloride Pre-filled Syringe | ISO 13485:2016; Not applicable items:7.5.3 Installation activities; 7.5.4 Servicing activities; 7.5.9.2 Particular requirements for implantable medical devices. | Ativo |
| NCC 23.09826 | REV.00 | 30/01/2026 | Scope: Design, development, manufacture, storage, packaging, shipping and distribution of tattoo ink (artificial pigmentation) | ISO 13485:2016; Not applicable items:7.5.3 – Installation activities; 7.5.4 -Technical assistance activities;7.5.10 – Property of the customer. | Ativo |
| NCC 22.071316 | REV.01 | 11/03/2025 | Scope:”Design, development, manufacturing, importing, sales and post-marketing supporting of monitoring and diagnostic medical devices” | ISO 13485:2016;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 servisse 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. | Ativo |
| NCC 23.09995 | REV.01 | 28/04/2026 | 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.” | Not applicable items: 7.5.3 (Installation activities) and 7.5.4 (Servicing activities). | Ativo |
| NCC 23.10044 | REV.00 | 25/05/2026 | Scope: “Design, manufacture and distribution of sterile dental implants, sterile and non-sterile prosthetic components and non-sterile surgical instruments” | Not applicable items: – 7.5.3: Installation activites; – 7.5.4: Servicing activities; – 7.5.10: Customer property. | Ativo |
| NCC 23.10094 | REV.00 | 15/06/2026 | Scope: Design, development, manufacturing, sales and distribution of: • Non-sterile implants for osteotomy and traumatology (upper and lower limbs) and cranio-maxillofacial; • Non-sterile reusable surgical instruments for osteotomy, traumatology (upper and lower limbs) support and craniomaxillofacial. • Sterile disposable surgical instruments (ETO) with coated for: craniomaxillofacial, upper and lower limbs coated with diamond and/or DLC, craniomaxillofacial for traumatology, arthroplasty and maxillofacial coated by DLC Black or Diamond; • Sterile surgical instruments (ETO) for surgical support on osteotomy, traumatology (upper and lower limbs) and craniomaxillofacial; • Disposable temporomandibular joint (ETO); • Sterile implants (ETO) with applicator (disposable) with wire andanchor for reconstruction of soft tissue; Sterile implants (ETO) with disposable applicator Button, wire and plate for fixation of fragments on syndesmotic fractures; • Sterile implants (ETO) without disposable applicator with wire and plate for reconstruction of anterior cruciate ligament. | Not applicable items: – 7.5.3 Installation activities – 7.5.4 Technical assistance activities – 7.5.10 Customer property. | Ativo |
| NCC 23.10153 | REV.00 | 31/07/2026 | Scope: Scope: “Design and development, manufacturing, exportation, distribution and servicing activities provided by the organization for electromedical equipment as optoelectronic, ultrasonic, radiofrequency or resistive dedicated to medical, aesthetic, helping to diagnosis or therapeutic use” | Not applicable items: – 7.5.3: Installation activites;- 7.5.5: Particular requirements for sterile medical devices – 7.5.6: Validation of processes for production and service provision – 7.5.7: Particular requirements for validation of processes for sterilization and sterile barrier system;- 7.5.9.2: Particular requirements for implantable medical devices. | Ativo |