Welcome to Guangdong Longxin Medical Device Co., Ltd. — Founded in 1982.
Company Profile
Guangdong Longxin Medical Device Co., Ltd.
Guangdong Longxin Medical Device Co., Ltd. was founded in 1982 by General Manager Huang Yongqiang and is located in Kaiping City, a renowned “Town of Diaolou” and a UNESCO World Heritage Site, situated in the central-southern part of Guangdong Province. The company is a specialized manufacturer of single-use medical devices, integrating research and development, production, processing, and sales. “Longxin” brand products primarily include:Single-use medical consumables such as infusion sets, syringes, blood collection devices, medical adhesives, indwelling needles, and ureteral stents..
Guangdong Longxin Company is among the first batch of private enterprises established in China following the country’s reform and opening-up policy, and it was also one of the earliest manufacturers nationwide to obtain a state‑approved medical device production license. Throughout successive periods of national policy changes, the company has remained steadfast in the medical device industry, emerging as one of the most renowned names in its sector. Over time, the company has undergone three distinct name transformations: from its predecessor, the “Longxin Hardware and Plastics Factory” founded in 1982, to the “Kaiping County Longxin Medical Plastics Factory,” and finally to its current name, “Guangdong Longxin Medical Device Co., Ltd.” From a modest factory initially set up with just RMB 300 in capital, it has grown into an enterprise with registered capital of RMB 90.18 million. Its operations have likewise expanded dramatically, evolving from a workshop of less than 50 square meters to a modern, garden‑style manufacturing facility spanning nearly 60,000 square meters. Today, the company occupies approximately 26,000 square meters of built‑up area, including a 4,300‑square‑meter Class 100,000 cleanroom that meets national GMP standards. Furthermore, to ensure product quality and guarantee that customers and patients receive effective, reliable, and safe medical devices, the company has established a fully equipped mold‑making workshop, a Class 100,000 cleanroom for producing packaging bags, automated ethylene oxide sterilization equipment, and a precision‑instrumented quality‑inspection center.
The company’s products are sold throughout China and in overseas markets, including developed regions such as Asia, Europe, and North America. Our high‑quality offerings and strong business reputation have earned the trust of a broad customer base, while competitive pricing, a win‑win philosophy, and exceptional service have secured their unwavering support. Since 1993, we have consistently supplied products to numerous renowned medical device companies ranked among the world’s top 100. To better serve the North American market and enhance after‑sales support, the company established Longxin Medical Devices USA in Chicago in 2002.
The company has established a comprehensive quality control system and has obtained ISO 9000 certification, ISO 13485 quality management system certification, U.S. FDA approval, and EU CE marking. The company is fully equipped with advanced testing instruments, ensuring the reliability and consistency of both purchased components and finished products.
All employees of Guangdong Longxin Medical Device Co., Ltd. remain steadfast in the belief that quality is the key to an enterprise’s survival, instilling unwavering confidence in every healthcare professional and dedicating themselves to safeguarding the health of every patient.
CE & ISO 13485 Certification
U.S. FDA Certification
Professional OEM/ODM
Global Logistics and Delivery
Development History
Forty Years of Steadfast Progress
From a 50-square-meter workshop to a global medical consumables manufacturer, every step has been driven by an unwavering commitment to quality.
1982
Dragon Heart Hardware and Plastics Factory
1988
Dragon Heart Medical Plastics Factory, Kaiping County
1996
Guangdong Dragon Heart Medical Device Co., Ltd.
2003
American Dragon Heart Medical Device Company
Honors and Qualifications
Qualification Certificate
Since 1998, the company has obtained EU CE certification, ISO 9000 certification, and ISO 13485 quality management system certification through TÜV Rheinland (Shenzhen) Co., Ltd.
Since 2004, the company’s syringes, infusion sets, and blood collection devices have been approved for product registration with the U.S. FDA.
