Leboo passed ISO 13485 and CE 0197 in 2009.

It is safe and  legal to sell our products in EU, Africa, South America, Asia.

EU market, we accordance with EC directive. Other market, we also could provide documents for  register.

For sterilie surgical gown, we will provide documents as below:

1, ISO 13485 certificate;

2, CE 0197 certificate;

3, Technical file and other documents.

With more than 10 year experience, Leboo could help you get register easier!