QUALITY & CERTIFICATIONS
Quality Engineered Into Every Test
From raw material to finished kit, quality is controlled at every step under an ISO 13485 quality management system and validated in our in-house laboratories.
Our Certifications
ISO 13485
Medical device quality management system.
CE Mark
Compliance for European and international markets.
NMPA (CFDA)
Approved to manufacture and trade IVD products in China.
Need our certificates and technical files for your registration?
A Controlled Manufacturing Environment
Every rapid test is produced in a controlled, contamination-free environment. Production runs in an ISO Class 8 cleanroom (100,000-grade), while critical microbiological work is carried out in a separate ISO Class 7 area (10,000-grade). Air cleanliness, temperature and humidity are continuously monitored, and zoned workflows separate processes to prevent cross-contamination, protecting the sensitivity and stability of every diagnostic kit.
Quality Control at Every Stage
Documentation & Technical Support
We provide the documentation you need to register and import, including CE documentation, instructions for use (IFU), product dossiers and technical files, and Certificates of Free Sale for export. Documentation scope varies by product and market.
Documents We Can Provide
- ✓ CE documentation
- ✓ Instructions for Use (IFU)
- ✓ Product dossiers & technical files
- ✓ Certificate of Free Sale (for export)
- ✓ Certificate of Origin / commercial documents
- ✓ Product specifications & COA (Certificate of Analysis)
Documentation scope varies by product and market.
Quality You Can Document and Trust
Request our certificates and technical files.