High-Quality Mouth Tape: Certifications and Material Safety Assurance

In the health and sleep-aid market, mouth tape has emerged as an innovative solution to improve oral breathing and sleep quality. Ensuring product safety, efficacy, and regulatory compliance is essential for the success of private-label brands.

1. EU Medical Device CE Certification

Our mouth tape products are certified under the EU Medical Device Notification , demonstrating full compliance with REGULATION (EU) 2017/745. This certification covers manufacturers, authorized representatives, and product registration, ensuring that mouth tape sold in Europe meets the highest safety and quality standards. The CE mark not only authorizes legal sales but also enhances consumer trust in the product.

2. ISO 13485 Medical Device Quality Management System

Our factory is certified under ISO 13485:2016, implementing a comprehensive medical device quality management system. From raw material sourcing and production to final packaging, every step is strictly controlled according to international standards, ensuring each piece of mouth tape meets medical-grade safety and performance requirements.

3. Material Safety and Biocompatibility

At the core of our mouth tape is high-quality, medical-grade adhesive, such as Henkel LOCTITE DURO-TAK 129A . This material has undergone rigorous safety testing, meets GB/T 16483-2008 standards, and is low in allergenicity and non-irritating. It maintains strong adhesion even in sweaty conditions, ensuring comfort and safety for users.

4. Private-Label and Customization Advantages

With CE certification and ISO 13485 quality management, brands can confidently offer customized mouth tape solutions, including colors, sizes, scents, and packaging designs. High-quality standards and material safety provide a competitive market edge while minimizing potential legal and safety risks.

5. Conclusion

By combining strict medical device certification, international quality management systems, and high-standard materials, our mouth tape products meet consumer demands for comfort and efficacy. They also offer brands a reliable foundation for marketing and cross-border sales, where quality and safety are the key to success.

6.Questions or Ideas?

I hope you found this guide helpful! If you have any questions or have a topic you'd like me to cover next, I'd love to hear from you.
Name:Vicky Zhou
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