Shanghai Youwen Medical Technology Co., Ltd.

Shanghai Youwen Medical Technology Co., Ltd. specializes in reusable device sterilization and disinfection containers, as well as hot and cold therapy products. Their portfolio includes compressible garments, sleeves, cuffs, and cold therapy systems like pads, wraps, and sets. These devices are designed for medical and post-operative use, such as managing swelling, pain, and deep vein thrombosis (DVT), in both clinical and homecare settings.

Shanghai Youwen Medical Technology Co., Ltd. is based in China. While the country of origin does not automatically determine regulatory compliance, their devices must meet the requirements of the jurisdictions where they are marketed. For example, their products are listed in the EU’s EUDAMED registry and the FDA’s UDI system, indicating they comply with those regions’ regulatory standards for medical devices.

Devices from Shanghai Youwen Medical Technology Co., Ltd. are listed in the EU’s EUDAMED registry and the FDA’s Unique Device Identification (UDI) system. This matters because inclusion in these registries demonstrates that the devices have undergone the necessary regulatory processes to be legally marketed in the EU and the US. Listing in these systems also helps healthcare providers and regulators verify the device’s identity, compliance status, and manufacturer details.

The devices manufactured by Shanghai Youwen Medical Technology Co., Ltd. are classified as Class I medical devices. This classification is typically assigned to low-risk products, such as reusable sterilization containers and hot/cold therapy items, which pose minimal risk to patients when used as intended. Class I devices still require compliance with essential safety and performance standards, but they generally undergo less stringent regulatory scrutiny compared to higher-risk classes.

The hot and cold therapy products from Shanghai Youwen Medical Technology Co., Ltd. are designed for medical and post-operative care, including managing swelling, reducing pain, and preventing complications like deep vein thrombosis (DVT). These devices—such as cold therapy pads, wraps, and systems—are used in both clinical settings (e.g., hospitals) and homecare environments to provide controlled thermal therapy for recovery and injury management.