Oneness Biotech Co., Ltd., had been granted with MDSAP (Medical Device Single Audit Program) certification for medical device quality management system.

Published Date:2025-01-29

Statement
No	1	Date of announcement	2025/01/29	Time of announcement	09:25:32
Subject	Oneness Biotech Co., Ltd., had been granted with MDSAP (Medical Device Single Audit Program) certification for medical device quality management system.
To which item it meets	paragraph 53			Date of events	2025/01/28
Date of occurrence of the event: 2025/01/28 Company name: ONENESS BIOTECH CO., LTD. Relationship to the Company (please enter ”head office” or ”subsidiaries”): head office Reciprocal shareholding ratios: NA Cause of occurrence: Oneness has received notification from the Notified Body, confirming that we comply with the MDSAP (Medical Device Single Audit Program) quality management system standards. The MDSAP certificate has been issued with the certificate number: MDSAP 803792 Countermeasures: None Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.): The MDSAP quality management system serves as the regulatory requirement for medical device manufacturers to apply for medical device certification in Canada, Brazil, and Australia. With the MDSAP certification, our company is eligible to apply for medical device product certification in these countries.