Dongguan Yixun Industrial Co., Ltd. Establishes 100,000 Grade ISO8 Cleanroom, Achieves ISO13485 Certification in 2024

Dongguan Yixun Industrial Co., Ltd. Invests in State-of-the-Art Medical Cleanroom, Expands into Precision Medical Device Manufacturing

Dongguan, China – 2024 – Dongguan Yixun Industrial Co., Ltd. proudly announces the completion of its advanced 100,000 grade ISO8 cleanroom establishment in 2024, followed by successful ISO13485 quality management system certification. These strategic advancements mark the company's significant entry into the medical device manufacturing sector, having secured partnerships with multiple medical industry clients specializing in precision components that require the highest standards of biocompatibility.

Elevating Manufacturing Standards with Medical-Grade Cleanroom

The establishment of a 100,000 grade ISO8 cleanroom represents Yixun Industrial's commitment to excellence in medical device production. This advanced cleanroom environment  effectively controls airborne particles and microorganisms, providing the ideal conditions for manufacturing sensitive medical components that meet stringent industry requirements.

Mr. David Cao Yixun Industrial's CEO, stated: "Medical devices directly impact patient health, leaving no room for compromise. The investment in our 100,000 grade ISO8 cleanroom demonstrates our unwavering commitment to medical product quality and serves as the foundation for our entry into the high-value medical device market."ISO13485 Certification: A Testament to Quality Excellence

In 2024, Yixun Industrial successfully obtained ISO13485 certification, a critical milestone in the company's quality management journey. ISO13485 is the internationally recognized quality management system standard specifically for medical devices, imposing rigorous requirements on design, development, production, and service delivery.

Achieving this certification confirms that Yixun Industrial's quality management systems align with international standards, enabling the company to deliver safer, more reliable products to medical clients while establishing a solid foundation for future international market expansion.

Strategic Entry into Medical Device Components Market

Following the cleanroom upgrade and quality system enhancements, Yixun Industrial has successfully attracted several medical industry clients, focusing on precision components that come into direct contact with the human body. The company's core medical products include:

1. PICC Power Catheter Overmolding Molds: Precision components for Peripherally Inserted Central Catheters, manufactured using specialized biocompatible materials to ensure safety and comfort during intravenous use.

2. Venipuncture Handles: These medical tools that directly contact patients' skin are produced by Yixun Industrial using high-grade biocompatible materials, enhanced through precision overmolding technology to guarantee both safety and durability.

Both product categories require materials that meet strict biocompatibility standards. Through advanced overmolding technology, Yixun Industrial ensures superior surface finish, sealing properties, and biological safety, significantly reducing patient discomfort and infection risks during medical procedures.

Overmolding Technology: Driving Innovation in Medical Components

Yixu Industrial's overmolding technology excels in the medical device sector. This process enables the perfect integration of different material properties, ensuring both the mechanical strength of components and the safety and comfort of surfaces contacting the human body. Head of Technology at Yixu Industrial, explains: "Our overmolding technology achieves molecular-level material integration, ensuring products are non-toxic and non-irritating, fully complying with the medical industry's strict biocompatibility requirements. This technology not only extends product lifespan but, more importantly, safeguards patient well-being."

Future Outlook

Yixun Industrial's leadership has expressed the company's commitment to continued investment in the medical device sector, with plans to enhance product quality and manufacturing processes to become a leading domestic provider of medical component solutions.

"As demand for healthcare services continues to grow globally, the medical device market presents tremendous opportunities. Yixun Industrial will uphold our 'Quality First, Safety Paramount' philosophy, providing the medical industry with high-quality, high-safety products that contribute to human health and well-being," concluded Mr. David.

About Dongguan Yixun Industrial Co., Ltd.

Dongguan Yixun Industrial Co., Ltd. is a high-tech enterprise specializing in precision mold manufacturing and plastic product production. The company operates advanced production facilities and maintains a professional technical team, dedicated to providing high-quality mold and product solutions across various industries. In recent years, Yixu Industrial has strategically pivoted to focus on the medical device sector, achieving significant success and recognition in this specialized field.