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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.

Guangdong Longxin Medical Device Co., Ltd.

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

Dragon Heart Hardware and Plastics Factory

Starting a business with an initial space of 50 square meters and an investment of just 300 yuan, we produce medicine bottles, pill boxes, and medication cups.

1988

Dragon Heart Medical Plastics Factory, Kaiping County

Dragon Heart Medical Plastics Factory, Kaiping County

The facility has been expanded to 1,000 square meters, with an investment of RMB 1.3 million, and new product lines have been added, including infusion sets and intravenous infusion needles.

1996

Guangdong Dragon Heart Medical Device Co., Ltd.

Guangdong Dragon Heart Medical Device Co., Ltd.

The production base has been expanded to 60,000 square meters, with an investment of RMB 90.18 million, establishing the company as a comprehensive medical device manufacturer.

2003

American Dragon Heart Medical Device Company

American Dragon Heart Medical Device Company

The company has established a branch in Chicago, USA, officially entering the North American market and fully rolling out its global strategy.

Honors and Qualifications

Qualification Certificate

German Rhine Certification

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.

U.S. FDA Certification

Since 2004, the company’s syringes, infusion sets, and blood collection devices have been approved for product registration with the U.S. FDA.

Internet Drug Information Service Qualification Certificate
Certificate of Qualification for Pharmaceutical Information Services
High-Tech Enterprise Certificate
Specialized, Sophisticated, and Novel Small and Medium-sized Enterprises
Guangdong Province Enterprise That Values Contracts and Upholds Creditworthiness