Quality Certifications & Credentials
ChiEnCheng holds ISO9001, ISO13485, CE, FDA, and 3C certifications, operating under a strict medical device quality management system to deliver reliable cooling solutions worldwide.
ISO9001
Quality Management System
Ensuring consistent product quality with continuous improvement processes.
ISO13485
Medical Device Quality Management
Compliant with international medical device regulations.
CE Mark
EU Market Access
Products meet EU safety, health, and environmental standards.
FDA Registered
US FDA Registration
Cleared for North American medical and laboratory markets.
CCC Certification
China Compulsory Certification
Compliant with Chinese national standards and regulations.
🏥 Medical Device Manufacturing Filing
ChiEnCheng is a legally registered medical device manufacturer. Filing number:
苏食药监械生产备20240001号
Issuing Authority: Jiangsu Provincial Medical Products Administration | Production Address: A-C2, Kunshan International E-Commerce Industrial Park, Kunshan, Jiangsu
Certification Details
| Certification | Type | Scope | Status |
|---|---|---|---|
| ISO9001:2015 | Quality Management | All product lines: ULT freezers, low temp freezers, medical refrigerators | ✓ Active |
| ISO13485:2016 | Medical Device QMS | Medical refrigerators, ULT freezers (medical device class) | ✓ Active |
| CE Mark | EU Market Access | All products distributed in the European Union | ✓ Active |
| FDA 510(k) | US FDA Registration | Medical refrigerators, ULT freezers | ✓ Registered |
| CCC | China Compulsory | Commercial and laboratory refrigeration equipment (China market) | ✓ Active |