Certificados Emitidos MDSAP
| Nº. Certificado | Revisão | Validade | Descrição | Regulamento | Status |
| NCC 24.10781 | Rev 00 | 11/06/2027 | Scope: “Manufacture, import, export, distribution, design, installation, technical assistance, training and rental of electromedical and medical-hospitalar devices in the neurosurgery and general surgery areas, including their consumables (sterile and non-sterile) and the development of software related to the healthcare area”. | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; 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. | ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 | Ativo |
| NCC 22.09095 | Rev.02 | 07/02/2025 | Scope: “Design, manufacture, technical assistance and distribution of laser hair removal equipment, tattoo removal and depigmentation equipment, laser emitting therapy equipment and fractional CO2 equipment”. | ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 | Ativo |
| NCC 22.09319 | REV.02 | 24/06/2025 | Scope: “Design, development, manufacturing, marketing and distribution of disposable sterile instrumental and surgical kits and reprocessed non-sterile instrumental and surgical kits, used in otorhinolaryngology, orthopedics and neurosurgery surgeries, orthopedic equipment and sterile surgical electrodes for neurosurgery and orthopedics” | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 22.09287 | REV.03 | 17/06/2025 | Scope: Design and development, manufacturing, sales, post-sales of dental products, diamond burs, carbide burs, polishers, dental strips and dental instruments | 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 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Canadá: Medical Devices Regulations – Part 1- SOR 98/282 EUA: 21 CFR 820.20 |
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 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 |
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 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº 67/2009 |
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 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 |
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 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 |
Ativo |
| NCC 22.07131 | REV.01 | 11/03/2025 | Scope:”Design, development, manufacturing, importing, sales and post-marketing supporting of monitoring and diagnostic medical devices” | ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Canadá: Medical Devices Regulations – Part 1- SOR 98/282 EUA : 21 CFR 820.20 |
Ativo |
| NCC 23.09995 | REV.01 | 28/04/2026 | 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.” |
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 23.10044 | REV.03 | 25/05/2026 | Scope: “Design, manufacture and distribution of sterile dental implants, sterile and non-sterile prosthetic components and non-sterile surgical instruments” | SO 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 / 21 CFR Part 821 – Device Tracking | Ativo |
| NCC 23.10153 | REV.00 | 31/07/2026 | 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” | ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 23.10460 | REV.00 | 29/12/2026 | Scope: The Quality Management System applies to the design, manufacture, distribution, sales and service of medical devices for cryolipolysis, radio frequency, ultrasound, electromagnetic stimulation and laser equipment. | ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 24.10597 | REV.00 | 19/03/2027 | Scope: Design, development, manufacturing, after-sales of products for cardiopulmonary use. Import, commercialization and after-sales of products for cardiopulmonary use and implantable neuromodulation devices and servicing of extracorporeal blood treatment equipments for the area of cardiovascular. | ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 EUA : 21 CFR 820.20 | Ativo |
| NCC 24.10663 | REV.00 | 17/04/2027 | Scope: Design, development, manufacture, sales, distribution, and technical assistance of the following products: – Automatic pressurized pen for mesotherapy, intradermotherapy and drug injection; – Electric pen for microneedling; – High-power focused micro and macro ultrasound equipment; – Microcontrolled laser equipment; – High-power micro and macro focused ultrasound equipment with radiofrequency microneedling; – Laser emission therapy equipment; Import and distribution of sterile health products for mesotherapy, intradermotherapy and microneedling | ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 24.10742 | REV.00 | 05/29/2027 | Scope: “Design, manufacture, package and distribution of Mard-Flex (Bipolar Electrode)” | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 23.10094 | REV.01 | 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 and anchor 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. – Sterile prothesis (ETO) for arthroplasty of partial elbow; – Sterile implants (ETO) for fixation of various bone fractures.” |
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 24.10933 | REV.00 | 19/08/2027 | Scope: “Design, manufacture, storage and distribution of solution for hypothermic storage of organ intended to transplantation | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 24.10965 | REV.00 | 03/09/2027 | Scope: “Design, Manufacture, Distribution, Sales, Installation and Service of Machine Raw Material for Medical Devices Industry Scope Particularity: Dental Chairs, Dental Delivery Units, Dental Light, Dental Water Units, Vaccum Pumps, Compressors, Dental X-Ray Equipment, Dental Software, Dental Equipmente for Prophylaxis, Dental Handpieces, Curing Lights, Dental Radiographic Image Scanner. Medical Ultrasound System and Small Steam Sterilizersm Intraoral Scanner” Not applicable items: 7.5.5 – Particular Requirements for Sterile Medical Devices 7.5.9.2 – Particular Requirements for Implantable Medical Devices | : ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 – Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 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) 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 | Ativo |
| NCC 24.11011 | REV.00 | 26/09/2027 | Scope: Scope: Design and development, manufacturing, sales and technical service of respiratory mechanics monitors and accessories | 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 | Ativo |