Certifications & Compliance
OxyCove chambers meet the highest international standards for medical device safety and quality.
CE Certified
Meets European Union safety, health, and environmental protection requirements for medical devices.
FDA Registered
Registered with the U.S. Food and Drug Administration as a Class II medical device.
ISO 13485
Certified quality management system for medical device manufacturing and distribution.
Safety Tested
Rigorous third-party safety testing including pressure vessel certification and electrical safety compliance.
Need Certification Documents?
Contact our team to request detailed certification reports and compliance documentation.
Request Documents