品質認證

Manufacturer declares that:

The above products comply with the following performance standards,

• 1. EN 60601-1
• 2. EN 60601-1-2
• 3. EN 60601-1-11

All devices in scope meet the essential requirements set out in Annex The manufacturing site for the above products complies with EN ISO 9001:2015/EN ISO13485:2016 Quality Management System Requirements for Medical Devices.

FDA CERTIFICATE 

FDA.8469 ((VIET NAM) WISE VISION)