Medical ultrasound coupling agent is an essential consumable in ultrasound diagnosis, and its quality directly affects the imaging effect and diagnostic accuracy. For medical device companies, distributors, or large medical institutions seeking to create their own brand of ultrasound coupling agents, choosing the ODM (Original Design Manufacturer) model can effectively utilize external resources and quickly launch high-quality products that meet their own needs. However, when choosing an ODM partner, it is essential to ensure that they have legitimate production qualifications and reliable quality assurance.
In China, medical ultrasound coupling agents are usually classified as second-class medical devices and are subject to corresponding registration approval for production and sales. Obtaining a second-class medical device registration certificate indicates that the product and its manufacturer have passed the strict review of the National Drug Administration, and their safety, effectiveness, and production quality management system meet the requirements of relevant national regulations and standards. This is the "identity card" for the product to legally circulate in the Chinese market. By choosing Pingchuang Medical, which holds the registration certificate, for ODM cooperation, customers do not need to bear the long and complex registration application process themselves and can directly utilize Pingchuang Medical's qualifications to quickly launch their own brand products into the market.
Pingchuang Medical's ODM customization services go beyond providing a compliant "shell". The service starts with a deep understanding of the customer's needs. Whether it is a special requirement for the viscosity of the coupling agent (to adapt to different transducers or examination sites), or the need to optimize the product's spreadability, erasability, or specific packaging forms (such as portable small bottles, sterile packaging for intracavitary transducers, or cost-effective large-volume bottles), Pingchuang Medical's research and development and technical team can provide professional solutions. Customers can choose from a variety of mature formulas available at Pingchuang Medical or propose new customized development requirements.
High-quality realization depends on strict manufacturing standards. Pingchuang Medical adheres to the use of medical-grade raw materials to ensure the biocompatibility of the product, its mildness to the skin without irritation, and its non-damaging to the ultrasound transducer. The production process is carried out in a 30,000 square meter Class 10,000 clean room, following GMP (Good Manufacturing Practice) standards, effectively controlling microbial and particle contamination. The entire production process is monitored under the ISO 13485 medical device quality management system to ensure the stability and consistency of product quality between batches.
Quality control is the key link to ensure high-quality products. Pingchuang Medical has established a professional QC laboratory, equipped with viscometers, sound velocity meters, pH meters, microbial detection equipment, and other comprehensive testing equipment for raw materials, semi-finished products, and finished products. The testing items cover key indicators such as acoustic performance, viscosity characteristics, pH value, microbial limit, and appearance. Only products that fully meet the standards can be released for storage. This strict quality control process ensures that every bottle of ODM custom coupling agent delivered to the customer has excellent performance and reliable safety.
Pingchuang Medical's ODM services also include professional design support. We can provide free packaging design services such as labels and outer boxes according to the customer's brand image, making the customized products have a unique visual recognition. At the same time, we will also ensure that the packaging design complies with the relevant regulations of medical device label identification. Free sample services allow customers to confirm the performance and appearance of the customized products before mass production.
Holding a Class II medical device registration certificate is the core advantage and legal guarantee for Pingchuang Medical to provide high-quality ODM custom services for ultrasound gels. Combining its strong research and development capabilities, strict manufacturing standards, comprehensive quality control, and comprehensive service support, Pingchuang Medical can provide customers with an efficient, reliable, and compliant ODM solution, helping customers easily own self-branded ultrasound gel products that meet market demand and have competitive advantages.
