Since its establishment in 1995, Wenzhou Fengrui Medical Devices Co., Ltd. has been dedicated to the R&D and manufacturing of medical diagnostic equipment, specializing in blood pressure monitoring and cardiopulmonary auscultation. As a leading Chinese enterprise in fundamental medical diagnostic devices, we boast an annual production capacity of 5 million professional sphygmomanometers, with product lines covering household, clinical, and special scenario applications across 8 major series and 126 refined models.
Multi-Certification Compliance: ISO 13485 / CE / MDR / FDA
WORKSHOP PRODUCTION
SPARE PARTS PRODUCTION WORKSHOP
As a certified medical device manufacturer, we are equipped with a 100000 level clean workshop and a 1000 square meter intelligent factory area, certified by ISO 13485 and MDR quality management system. Integrated intelligent automation production line and real-time monitoring system, using AI driven multi-level quality inspection to achieve vertical control of the entire process from raw materials to sterilization, with a first inspection pass rate of 98.6%.
ASSEMBLY WORKSHOP
The assembly workshop maintains a 100000-class cleanroom environment with automated production lines and precision testing equipment. Technicians work at modular stations under strict GMP standards. Key processes include stethoscope diaphragm pressing, sphygmomanometer valve leakage tests, and dual-operator calibration. All products comply with ISO 13485, with critical stations equipped with HD vision inspection systems ensuring clinical-grade accuracy.
SCHOOL WATCH WORKSHOP
The meter calibration workshop operates in a 10000-class cleanroom with temperature/humidity control, specializing in sphygmomanometer gauge calibration. Data is digitally archived. Compliant with ISO 13485 and NK 270 standards, critical stations feature anti-vibration platforms. Full inspection pass rate reaches 99.7%, meeting CU-FDA clinical requirement.
RESTORATION WORKSHOP
The recheck workshop conducts final inspection for sphygmomanometer gauges in a 10000-class cleanroom with temperature-controlled stations. Compliant with ISO 13485 and JIG 270 re-inspection protocols, the workshop operates in anti-magnetic environments with full batch traceability, achieving 99.9% pass rate. Supports FDA/CE/MDR certifications.
PACKAGING WORKSHOP
The packaging workshop implements terminal protection for medical devices, utilizing semi-automatic cartoning machines, heat-shrink film packaging lines, and laser marking equipment to achieve integrated packaging of blood pressure monitors with accessories and manuals. Each batch undergoes label verification, seal integrity checks, and anti-counterfeit code activation via vision inspection systems.
