2025 Top 10 face mask ce fda Suppliers in China

Introduction to Face Mask CE and FDA Certification

Face masks are essential personal protective equipment, especially in the context of global health concerns. The CE and FDA certifications are two crucial approvals for face masks entering different markets.

The CE mark is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). It is a mandatory requirement for many products, including face masks, to be legally placed on the market in the EEA.

The FDA (Food and Drug Administration) in the United States regulates the safety and effectiveness of medical devices, including face masks. FDA approval is necessary for face masks to be sold in the US market. It ensures that the masks meet certain quality and performance criteria.

Now, let's introduce the top 10 face mask CE FDA suppliers in China in 2025.

1. Guangdong Beeda Medical Technology Co., Ltd

Guangdong Beeda Medical Technology Co., Ltd is a leading player in the medical equipment field, especially in the production of high - quality face masks. The company is committed to research and development, production, and sales of medical products. It has a modern production base equipped with advanced production lines and testing equipment.

The R & D team of Guangdong Beeda Medical Technology Co., Ltd is composed of a group of experts with rich experience in the medical industry. They are dedicated to improving the quality and performance of face masks. The company adheres to strict quality control systems from raw material procurement to the final product. Only high - grade non - woven fabrics, filter materials, and elastic bands are selected to ensure the comfort and protection of the masks.

In terms of CE and FDA certifications, the company has made great efforts. It has established a complete quality management system in line with international standards. For the CE certification process, the company has carefully studied the European regulations and requirements, and has made corresponding adjustments to its production technology and product design. It has also passed a series of strict tests and audits to obtain the CE mark, which allows its face masks to enter the European market smoothly.

For the FDA certification, Guangdong Beeda Medical Technology Co., Ltd has actively cooperated with relevant US regulatory agencies. It has provided detailed product information, including production processes, material compositions, and performance test reports. Through continuous communication and improvement, the company has finally obtained the FDA approval, which is a strong proof of the high quality of its face masks.

The company's website is https://www.beeda-teyoudas.com/, where customers can find detailed product information, including product specifications, quality certificates, and contact information.

Features and Advantages:

• High - end R & D: Continuously invests in research and development to improve the performance of face masks, such as enhancing filtration efficiency and breathability.
• Strict Quality Control: Has a comprehensive quality control system that covers every aspect of production, ensuring product stability and quality.
• International Certification: Holds both CE and FDA certifications, which means its products can enter the European and US markets, expanding its market share.

2. 3M China Limited

3M is a well - known global company, and its Chinese subsidiary, 3M China Limited, is also a major supplier of face masks. 3M has a long - standing reputation for innovation and quality in the field of personal protective equipment.

The company has a large - scale production base in China, equipped with state - of - the - art manufacturing technology. It uses advanced materials and production processes to produce face masks. For example, 3M's face masks often use its patented filter materials, which can effectively filter out fine particles, bacteria, and viruses.

In terms of CE and FDA certifications, 3M has a professional regulatory affairs team. They are well - versed in the European and US regulatory requirements. For CE certification, 3M China Limited has a deep understanding of the European Union's medical device regulations. It conducts regular internal audits and product testing to ensure that its face masks meet the strict European standards.

For the FDA certification, 3M has a long - term relationship with the US regulatory agency. It has a complete set of documentation and data management systems to provide accurate and detailed information about its products. The company's face masks have been widely recognized in the US market for their high quality and performance.

Features and Advantages:

• Global Brand Reputation: 3M is a world - famous brand, which gives consumers high confidence in the quality of its face masks.
• Advanced Technology: The use of patented filter materials and advanced production processes ensures high - performance face masks.
• Regulatory Expertise: A professional regulatory affairs team can quickly adapt to changes in international regulations and ensure product compliance.

3. Shanghai Dasheng Health Products Co., Ltd

Shanghai Dasheng Health Products Co., Ltd is a large - scale enterprise focusing on the production of health products, with face masks being one of its core products. The company has a large - scale production base and a complete industrial chain.

It has its own raw material production facilities, which can ensure the stable supply of high - quality raw materials for face mask production. The company also pays great attention to product innovation. It has established a research and development center, where a group of experts are constantly exploring new materials and production processes to improve the performance of face masks.

In terms of CE and FDA certifications, Shanghai Dasheng Health Products Co., Ltd has a dedicated quality management department. For CE certification, the department has in - depth research on the European Union's medical device directives. It has carried out a series of product improvement measures according to the European standards, such as improving the packaging design and product labeling.

For the FDA certification, the company has actively participated in the US regulatory agency's training and guidance programs. It has continuously improved its product quality management system and provided detailed product information for FDA review.

Features and Advantages:

• Complete Industrial Chain: The self - owned raw material production facilities can control the quality of raw materials and reduce production costs.
• Innovation - Driven: The research and development center continuously promotes product innovation, which can meet the changing market demands.
• Quality - Oriented Management: A dedicated quality management department ensures strict compliance with international certification requirements.

4. Anqing Heye New Materials Co., Ltd

Anqing Heye New Materials Co., Ltd is mainly engaged in the research and development, production, and sales of new materials, and has made remarkable achievements in the field of face mask production. The company focuses on the development and application of new filter materials for face masks.

It has a strong R & D team composed of experts in materials science and engineering. They are committed to developing new materials with high filtration efficiency, low resistance, and good comfort. The company's production base is equipped with advanced production equipment, which can ensure the large - scale and high - quality production of face masks.

In terms of CE and FDA certifications, Anqing Heye New Materials Co., Ltd has a clear understanding of the importance of international certifications. For CE certification, the company has adjusted its production process and product design according to the European Union's relevant regulations. It has also established a traceability system for raw materials and products to meet the European requirements for product quality control.

For the FDA certification, the company has actively cooperated with US testing institutions. It has carried out a large number of product performance tests and provided detailed test reports to the FDA. Through continuous efforts, the company has obtained the necessary approvals.

Features and Advantages:

• New Material Innovation: Focuses on the development of new filter materials, which can provide face masks with better performance.
• Advanced Production Equipment: Ensures high - quality and large - scale production of face masks.
• International Certification Compliance: Actively meets international certification requirements, which helps to expand the international market.

5. Jiangsu Kangde Xin Composite Material Group Co., Ltd

Jiangsu Kangde Xin Composite Material Group Co., Ltd is a well - known enterprise in the composite material field. It has extended its business to the face mask production. The company uses its advanced composite material technology to produce high - performance face masks.

The company has a large - scale production base and a complete set of production lines. It can produce a variety of face masks, including medical surgical masks, N95 respirators, etc. The company's R & D team is constantly exploring new ways to combine different materials to improve the performance of face masks, such as enhancing the antibacterial and antiviral properties.

In terms of CE and FDA certifications, Jiangsu Kangde Xin Composite Material Group Co., Ltd has a professional quality control team. For CE certification, the team has a deep understanding of the European Union's medical device regulations. It has carried out strict internal audits and product inspections to ensure that the face masks meet the European standards.

For the FDA certification, the company has established a good communication mechanism with the US regulatory agency. It has provided detailed product information and test reports in a timely manner, and has made corresponding improvements according to the FDA's feedback.

Features and Advantages:

• Composite Material Technology: The application of advanced composite material technology can produce face masks with unique performance.
• Diversified Product Portfolio: Can produce a variety of face masks to meet different market needs.
• Professional Quality Control: A professional quality control team ensures product compliance with international certifications.

6. Shandong Blue Sail Medical Co., Ltd

Shandong Blue Sail Medical Co., Ltd is a leading medical device manufacturer in China. It has a wide range of medical products, including face masks. The company has a strong production capacity and a high - level quality management system.

The company's face mask production base is equipped with advanced production equipment and strict quality control procedures. It uses high - quality raw materials to ensure the safety and effectiveness of face masks. The company also pays attention to product innovation. It has developed a series of new - style face masks, such as masks with adjustable straps and improved breathing valves.

In terms of CE and FDA certifications, Shandong Blue Sail Medical Co., Ltd has a dedicated regulatory affairs department. For CE certification, the department has in - depth research on the European Union's medical device regulations. It has carried out a series of product improvement measures, such as improving the product's biocompatibility and mechanical properties.

For the FDA certification, the company has actively cooperated with the US regulatory agency. It has provided detailed product information, including production processes, quality control records, and clinical trial data. Through continuous efforts, the company has obtained the necessary approvals.

Features and Advantages:

• Strong Production Capacity: Can meet the large - scale market demand for face masks.
• Product Innovation: Continuously develops new - style face masks to improve user experience.
• Regulatory Compliance: A dedicated regulatory affairs department ensures compliance with international certifications.

7. Shenzhen Yuyue Medical Equipment Co., Ltd

Shenzhen Yuyue Medical Equipment Co., Ltd is a professional medical equipment manufacturer. It has a long - standing history in the medical field and has rich experience in face mask production.

The company has a modern production base and a complete set of quality management systems. It uses advanced production technology to produce face masks with high quality and stability. The company's R & D team is constantly working on improving the performance of face masks, such as increasing the filtration efficiency and reducing the resistance.

In terms of CE and FDA certifications, Shenzhen Yuyue Medical Equipment Co., Ltd has a clear strategy. For CE certification, the company has carefully studied the European Union's medical device regulations and has adjusted its production process and product design accordingly. It has also established a good relationship with European testing institutions to ensure the smooth progress of the certification process.

For the FDA certification, the company has actively participated in the US regulatory agency's activities. It has provided detailed product information and has made corresponding improvements according to the FDA's requirements.

Features and Advantages:

• Rich Industry Experience: A long - standing history in the medical field provides valuable experience for face mask production.
• Advanced Production Technology: Ensures high - quality and stable production of face masks.
• Certification Strategy: A clear strategy for obtaining CE and FDA certifications helps to enter international markets.

8. Zhejiang Huahai Pharmaceutical Co., Ltd

Although Zhejiang Huahai Pharmaceutical Co., Ltd is mainly known for its pharmaceutical business, it has also entered the face mask production field. The company has high - standard production facilities and a strict quality control system.

The company uses its pharmaceutical - grade production technology to ensure the high quality of face masks. It pays attention to the selection of raw materials, only using high - purity and non - toxic materials. The company's R & D team is also exploring the application of new pharmaceutical technologies in face mask production, such as adding antibacterial and antiviral agents.

In terms of CE and FDA certifications, Zhejiang Huahai Pharmaceutical Co., Ltd has a professional quality management team. For CE certification, the team has a deep understanding of the European Union's medical device regulations. It has carried out strict internal audits and product inspections to ensure that the face masks meet the European standards.

For the FDA certification, the company has actively cooperated with the US regulatory agency. It has provided detailed product information, including production processes, quality control records, and safety data. Through continuous efforts, the company has obtained the necessary approvals.

Features and Advantages:

• Pharmaceutical - Grade Production: The use of pharmaceutical - grade production technology ensures high - quality face masks.
• New Technology Application: The exploration of new pharmaceutical technologies in face mask production can provide unique product features.
• Quality - Driven Management: A professional quality management team ensures compliance with international certifications.

9. Henan Pingyuan New Medical Equipment Co., Ltd

Henan Pingyuan New Medical Equipment Co., Ltd is a specialized medical equipment manufacturer focusing on the production of face masks. The company has a large - scale production base and a complete set of production lines.

It has its own R & D center, where experts are constantly working on improving the design and performance of face masks. The company pays attention to the comfort of face masks, using soft and breathable materials. In addition, it also focuses on the environmental protection of products, using recyclable materials in the production process.

In terms of CE and FDA certifications, Henan Pingyuan New Medical Equipment Co., Ltd has a dedicated certification team. For CE certification, the team has in - depth research on the European Union's medical device regulations. It has carried out a series of product improvement measures, such as improving the product's environmental protection performance and user - friendliness.

For the FDA certification, the company has actively cooperated with the US regulatory agency. It has provided detailed product information, including production processes, quality control records, and environmental impact reports. Through continuous efforts, the company has obtained the necessary approvals.

Features and Advantages:

• Comfort - Oriented Design: Focuses on the comfort of face masks, which can improve user acceptance.
• Environmental Protection Awareness: The use of recyclable materials in production meets the growing environmental protection requirements.
• Certification - Dedicated Team: A dedicated certification team ensures the efficient progress of obtaining CE and FDA certifications.

10. Hubei Hongri Kangtai Medical Products Co., Ltd

Hubei Hongri Kangtai Medical Products Co., Ltd is a local - well - known medical products manufacturer in Hubei. It has a long - standing history in the production of face masks and other medical products.

The company has a stable supply chain of raw materials, which can ensure the continuous production of face masks. It has also established a complete quality control system, from raw material inspection to the final product inspection. The company's R & D team is constantly working on improving the product quality and performance, such as enhancing the antibacterial ability of face masks.

In terms of CE and FDA certifications, Hubei Hongri Kangtai Medical Products Co., Ltd has a professional regulatory compliance team. For CE certification, the team has a deep understanding of the European Union's medical device regulations. It has carried out strict internal audits and product inspections to ensure that the face masks meet the European standards.

For the FDA certification, the company has actively cooperated with the US regulatory agency. It has provided detailed product information, including production processes, quality control records, and product performance data. Through continuous efforts, the company has obtained the necessary approvals.

Features and Advantages:

• Stable Supply Chain: Ensures the continuous production of face masks, which is important for meeting market demand.
• Quality Control System: A complete quality control system ensures product quality and stability.
• Regulatory Compliance: A professional regulatory compliance team ensures compliance with international certifications.

Conclusion

The above - mentioned 10 face mask suppliers in China have their own unique features and advantages in terms of face mask production and obtaining CE and FDA certifications. These companies cover a wide range of aspects, from large - scale production capacity, advanced technology, product innovation, to strict quality control and regulatory compliance.

With the increasing demand for face masks in the global market, these suppliers are well - positioned to play an important role. Their CE and FDA certifications not only ensure the quality of their products but also open the doors to the European and US markets. As the industry continues to develop, these companies are likely to further improve their products and services, and contribute more to the global fight against various health threats through high - quality face masks.