zh-twzhen
zh-twzhen

NEWS

合一生技股份有限公司 / 2022 / Oneness Biotech Co., Ltd. receives ISO13485 Medical Devices Quality Management System Certificate.

Oneness Biotech Co., Ltd. receives ISO13485 Medical Devices Quality Management System Certificate.

2022-04-08

Published Date:2022-04-08

Original Link:https://www.onenessbio.com/en/news_detail158_3.htm

No 2 Date of announcement 2022/04/08 Time of announcement 18:13:27
Subject Oneness Biotech Co., Ltd. receives ISO13485 Medical Devices Quality Management System Certificate.
To which item it meets paragraph 53 Date of events 2022/04/08
Statement
  1. Date of occurrence of the event:2022/04/08
  2. Company name:ONENESS BIOTECH CO., LTD.
  3. Relationship to the Company (please enter ”head office” or   ”subsidiaries”):head office
  4. Reciprocal shareholding ratios:NA
  5. Cause of occurrence:The Company has been notified by the Accreditation Body that the Company is in compliance with ISO 13485 Medical Devices Quality Management Systems Standards. The ISO 13485 certificate is issued under number TW22/00000011.
  6. Countermeasures:None
  7. Any other matters that need to be specified:
    ISO13485 Medical Devices Quality Management System is a primary pathway for medical device manufacturers to apply the European Commission (EC) CE Marking. The Company has been a certified manufacturer of medical device and will be eligible to file an application to EC for medical device CE certification in Europe.