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Zhongshan Xinwei Weaving Co., Ltd. announced that its medical-grade Hook and Loop series products officially passed the U.S. Food and Drug Administration (FDA) certification in April 2025, complying with 21 CFR Part 820 quality system regulations and related medical device accessory standards.
**The Significance of FDA Certification**
FDA certification is a necessary threshold for entering the U.S. medical device market and one of the most credible certifications in the global medical industry. The acquisition of this certification marks that Xinwei Weaving's medical-grade Hook and Loop products have reached the highest U.S. regulatory standards in terms of safety, biocompatibility, and quality management.
**Certified Product Range**
- 1Hook and Loop for orthopedic braces — knee braces, wrist fixation straps, ankle supports
- 2Hook and Loop for blood pressure cuff — washable, dimensionally stable type
- 3Wearable medical device fixation straps — heart rate monitoring bands, pulse oximeter straps
- 4Medical equipment cable management ties — for operating rooms and ICU equipment
The General Manager of Xinwei Weaving stated: "Obtaining FDA certification is an important milestone for the company to enter the North American medical market. We will continue to increase R&D investment to provide safer and more reliable Hook and Loop solutions for global medical device manufacturers."
Xinwei Weaving continuously produces to German quality standards, providing stable and reliable supply chain solutions for 500+ global enterprises.