Manufacturing site is complying with quality management system for medical device 2020. Operation site is certified by MDA approved CAB (certified assessor body). Assessed to be in accordance with the requirements of international Quality Management System for Medical Advice. ISO 13485 is an international standard that serves as a model for medical device manufacturers to meet regulatory requirements.

Initial issuance Nov 2020. Valid through 2023.

Obtained in Dec 2020 valid through 2025.

Obtained in Dec 2020 valid through Dec 2021. The FDA is responsible for protecting and promoting public health through the control and supervision of products. FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.”

Obtained Jan 2021 valid through Jan 2022.
CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.