On April 1, 2025, QuWin announced the completion of the delivery of 240 boxes of professional-grade hot-pressed hook ring products to North American medical customers, marking a milestone in QuWin's high-end medical device supporting field.
1. Medical-grade quality wins recognition from top customers
The hot-pressed hooks delivered this time have industry-leading features:
- Passed ISO 13485 medical device quality management system certification
- Meets FDA 21 CFR 177.2600 medical material standards
- Uses biocompatible PUR hot melt adhesive formula
- Sterilization tolerance reaches EO/gamma ray dual standards
Customer evaluation: "The product performance fully meets the stringent requirements of our cardiac monitoring equipment."
2. Full-process quality control system
To ensure the reliability of medical-grade products:
- Raw materials: Use US FDA-certified substrates
- Production: Special production in Class 1,000 dust-free workshops
- Testing: Implementation of 100% full inspection system
- Packaging: Medical-grade clean packaging environment
3. Technological innovation solves industry pain points
Product breakthrough advantages:
- Achieve 72 hours of continuous bonding without displacement
- No residue or skin irritation when removed
- Maintain stable viscosity at body temperature
- Supports penetration of medical images such as X-rays/CT
4. The strategic layout has achieved initial results
The far-reaching significance of this order:
- The first order to enter the North American medical supply chain
- It is expected to drive an annual sales increase of 30 million yuan
- Accelerate the comprehensive upgrade of the company's medical qualifications
5. Establish a long-term partnership
The two parties have signed:
- A three-year framework supply agreement
- A joint research and development memorandum
- A quality co-construction plan
The customer promised to include QuWin in the core supplier system.
QuWin General Manager Wei Wenbin said: "The medical field is a key direction for our strategic transformation. In the next three years, we will invest 10 million yuan to build a GMP workshop and strive to become a global leader in medical bonding solutions." This successful delivery not only achieved business upgrades, but also demonstrated the technical strength of Chinese manufacturing in the high-end medical field.
