Shanghai Jianying Medical Technology Co., Ltd.

Shanghai Jianying Medical Technology Co., Ltd. specializes in reusable headbands and fetal monitoring belts. These devices are designed for obstetric applications, specifically for continuous or intermittent monitoring of fetal heart rate during pregnancy and labor. The focus is on providing healthcare providers with real-time data to support maternal and fetal health assessment.

The company is based in China. While the location influences regulatory pathways, it does not inherently determine whether its devices are authorized—individual devices must meet the regulatory requirements of the markets they enter. For example, its Class I devices are listed in the EU’s eudamed registry and the FDA’s UDI system, demonstrating compliance with those jurisdictions’ standards.

Devices from Shanghai Jianying Medical Technology Co., Ltd. are listed in the EU’s eudamed registry and the FDA’s UDI system. These registries serve as official databases where authorized medical devices are documented, ensuring transparency for healthcare providers, regulators, and patients. Listing in these systems confirms the devices meet the necessary regulatory criteria for their respective markets.

The company’s devices, such as the MEZUT and fetal monitoring belts, are classified as Class I medical devices. This classification is typically assigned to low-risk products like reusable headbands and monitoring belts, where the risk to patients is minimal. Class I devices often undergo less stringent regulatory scrutiny than higher-risk categories but still require compliance with basic safety and performance standards.