Amaax International highlights the following certifications and quality standards for its surgical, dental, and medical instruments:
Main Certifications
- ISO 9001 — Quality Management System
- ISO 13485 — Medical Devices Quality Management System
- CE Certification / CE Marked — European conformity for medical devices
- FDA Compliance / FDA Listed — Referenced for medical device quality compliance
Additional Quality & Manufacturing Standards
Amaax International also states compliance or adherence to:
- ASTM-F899 Surgical Grade Steel
- Passivation / Rust Prevention Procedures
- Ultrasonic Cleaning Standards
- Boil Test, Shape Test & Performance Test QC
- UDI-compatible laser marking capability
- German & Japanese stainless steel materials
Explore Our Quality Certificates
