AMBISEA is an ISO13485 company and hold CE mark for several products. Any of our products can have CE, medical CE, ISO, SFDA, or FDA approval, but have different certifications. If you want to know what certifications a product has please contact us. We are always applying and updating. We can also apply for certifications on behalf of our customers or support them with their registration process.

Our company has the following certifications and registrations :

- US FDA Registration #3008951083

- China SFDA Registration

- ISO13485 and CE Certification from TUV Rheinland

   iso_logo   fda-logo  TUV Logo and Registration