Oneness Biotech Co., Ltd. receives ISO13485 Medical
Devices Quality Management System Certificate.
Date of events
2022/04/08
To which item it meets
paragraph 53
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.
