With the increasing importance of precision medicine, ultrasound examination has become an indispensable tool for clinical diagnosis due to its non-invasive, real-time, and convenient characteristics. Medical Ultrasound Gel, as the key medium connecting the probe to the human body, its quality directly determines whether the ultrasound can be effectively transmitted, thereby affecting the imaging quality and diagnostic accuracy.
Therefore, when medical institutions, equipment manufacturers, and brand owners choose ultrasound coupling gel, they have very high requirements for the professionalism, compliance, and manufacturing capabilities of the production manufacturers. It is crucial to find an OEM manufacturer that meets the medical device-grade manufacturing standards. Pingchuang Medical Group is a representative of such a manufacturing model.
Medical ultrasound coupling agents are classified as medical devices in many countries and are subject to strict management. This means that their production must comply with standards far beyond those of ordinary daily chemical products. Manufacturers must have the corresponding production qualifications, such as the Medical Device Production License and Product Registration Certificate in China. Every link in the production process, including the production environment, quality management system, raw material control, process validation, product inspection and release, must meet the relevant regulations of medical devices to ensure the safety, effectiveness, and stability of the product.
Pingchuang Medical deeply understands the special properties of medical ultrasound coupling agents and builds its manufacturing system around this core. The company holds a second-class medical device registration certificate issued by the National Medical Products Administration, proving that its products meet China's regulatory requirements and have the qualifications for legal sales in the domestic market. This is an authoritative recognition of the safety and effectiveness of its products and also the basis for customer cooperation.
To achieve and maintain the level of medical device manufacturing, Pingchuang Medical has made huge investments in hardware facilities. Within a modern factory covering 16,000 square meters, a 3,000-square-meter ten-thousand-level clean room has been specially established. This high-standard clean environment effectively isolates dust particles and microorganisms during the production process, ensuring the purity of the ultrasound coupling agent, which is crucial for preventing cross-infection and ensuring patient safety.
Quality management is the soul of medical device production. Pingchuang Medical fully implements the ISO 13485 Medical Device Quality Management System and produces in strict accordance with the GMP (Good Manufacturing Practice) standards. This means that from the audit of raw material suppliers, incoming inspection, to the monitoring of key parameters during the production process, sterile control (where applicable), to the physical and chemical properties (viscosity, pH, acoustic conductivity, etc.) of the finished product, microbial limits, and biocompatibility, there are rigorous operational procedures and a complete record traceability system.
The selection of raw materials is directly related to the final quality and safety of the product. Pingchuang Medical adheres to the use of high-quality, medical-grade raw materials to ensure good biocompatibility, non-irritating and non-sensitizing to the skin, and stable chemical properties without damaging the ultrasonic probe. The strict raw material control system lays a solid foundation for the safety and reliability of the product from the source.
In addition to strong manufacturing capabilities and strict quality control, Pingchuang Medical also provides professional OEM/ODM services. Customers can choose from their extensive library of mature formulas or customize according to specific requirements for viscosity, color, packaging (such as sterile independent packaging, large-volume bottle packaging, etc.). One-stop services include assisting with packaging design, free samples, providing regulatory consultation and qualification authorization, greatly simplifying the customer's project process.
Pingchuang Medical's products not only meet the requirements of the Chinese market, but also the obtained US FDA 510K and EU CE certifications prove that they meet the stringent standards of the mainstream international market and have strong global supply capabilities. With experience in exporting to 76 countries and regions, it is better able to serve customers with international market expansion needs. Choosing Pingchuang Medical as the OEM manufacturer of medical ultrasonic coupling agents means choosing professional capabilities that meet medical device manufacturing standards, strict quality assurance, comprehensive regulatory compliance, and reliable global supply services.
