About Us

OEM & ODM

As an OEM manufacturer, we supply products branded according to your marketing requirements and presented to comply with all of the regulations in your market.

For the EU market, we can manufacture the product for you through the OBL route, providing you are ISO 13485 certificate accredited by an EU Notified Body.

For the US market, the moist fibrous wound dressing is a Class I device and therefore 510K exempted.

We are also an ODM manufacturer, we can design a dedicated wound dressing based on specifications that accord with your requirements. We will build up all necessary technical files or design dossiers and help you to get through the regulatory registering procedures.

Tell us what you want and our professional regulatory services will flexibly handle your dedicated needs.