The water based lubricant OEM market is mixed, with many seemingly upscale trading companies often having only a few simple offices, while the real source manufacturers are hidden in industrial zones. For brands aiming for long-term development, failing to conduct thorough vetting before OEM can easily lead to unstable quality and compliance issues. To determine if a factory has "genuine strength," you must see through marketing packaging and focus on the following three hard indicators.
First, consider the "qualification value." This is not just about the business license but whether it holds a Class II medical device registration certificate, ISO13485 quality management certification, and export-related US FDA 510K and EU CE certifications. These certificates cannot be bought with money; they represent that the factory meets international medical standards in cleanliness and production quality control. Next, look at the "production base scale." Does it have a 100,000-level cleanroom? Does it strictly follow GMP standards? A genuine modern factory is usually equipped with fully automatic vacuum emulsification equipment and dozens of automated production lines, with a daily output capacity of over 100,000 units to ensure stable large-scale delivery.
Finally, review the "cooperation performance records." Inquire whether they have long-term OEM cases with leading domestic brands or century-old companies from Japan, Europe, or the U.S. Major brands have extremely strict factory inspection processes. Factories endorsed by big brands naturally have supply chain management and on-time delivery rates that can withstand scrutiny. Truly capable factories also offer "nanny-style" services, from free packaging design to qualification authorization. Through this one-stop integration, brand owners can significantly reduce R&D and design costs and achieve an efficient brand launch.
Pingchuang Medical has a 16,000 sqm modern factory and a 3,000 sqm Class 100,000 cleanroom, strictly adhering to GMP production standards. Holding FDA 510K, EU CE, and Class II medical device certificates, it has established global compliance credentials. We produce 600,000 units daily and maintain long-term cooperation with renowned companies such as Beilele and Japan Matsuyoshi Medical.
