Certification and Regulation
August 21, 2023
Existing certifications:
Our company and factory have passed ISO 13485, 1SO 9001, MDSAP, BSCI and BRC.
All our products are CE marked.
Our fertility test series is all FDA 510k cleared too. Besides, Digital Pregnancy and Ovulation tests are ANVISA, UKCA, and HSA approved.
Regulation assitance:
We have a professional regulation team who is experienced in the regulation in CE IVDR, UKCA, US FDA, TGA, Canada, Mexico, Brazil, as well as South American, Middle East, Asian and African areas. We can assist you in the regulation to your local health ministry.