Compliance & Certifications
At Claveclub, transparency and regulatory compliance are fundamental. The Enbio autoclaves we distribute meet the applicable medical device regulations and quality standards.
Enbio autoclaves are FDA 510(k) cleared medical devices, designed to provide safe and reliable sterilization for professional use in healthcare, dental, and beauty practices.
For your convenience, the official regulatory documents, certifications, and technical documentation related to Enbio autoclaves are available below for download.
Regulatory Compliance
-
FDA 510(k) Clearance Letter. View FDA 510(k) Clearance Letter
The Enbio S autoclave is cleared by the U.S. Food and Drug Administration (FDA) through the 510(k) process as a Class II medical device for steam sterilization.
Quality Certifications
-
MDSAP Certification Download PDF
Enbio operates under an internationally recognized medical device quality management system certified according to ISO 13485 and the Medical Device Single Audit Program (MDSAP), ensuring compliance with regulatory requirements in multiple jurisdictions.
Technical Documentation
-
U.S. User Manual Enbio S/PRO. View User Manual
- U.S. User Manual Enbio Beauty. View User Manual
The documents provided on this page are published for informational purposes. For detailed regulatory information regarding specific devices, please refer to the manufacturer’s official documentation.