Certifications & Registrations
Our commitment to quality, safety, and regulatory compliance.
ISO 13485:2016
Quality management system for medical devices. Our facility is certified to ISO 13485 by an accredited certification body.
FDA Establishment Registration
Registration No. 3016195240. Our facility and product listings are registered with the U.S. Food and Drug Administration.
CE Marking (EU MDR 2017/745)
Stage 1 audit completed by SGS. Stage 2 in progress. Our anesthesia and respiratory products are CE MDR compliant.
NMPA Registrations
35+ product registrations with China's National Medical Products Administration, covering anesthesia circuits, masks, catheters, and surgical products.
Free Sale Certificate (CFS)
Certificate for Exportation of Medical Devices issued by National Medical Products Administration (No. MDHA2026000001), valid through July 2027. Covering 35 product categories.
Quality Assurance
Our quality management system covers the entire production process — from incoming raw material inspection to in-process quality control, final product testing, and sterile packaging validation. We maintain full traceability through batch numbering and detailed production records.
All products are manufactured in accordance with applicable international standards and regulations. Documentation packages are available for regulatory submissions, including CSDT technical files for ASEAN registrations.
Need Certification Documents?
Contact us for product-specific certificates, technical files, and regulatory support.