山东新华医疗器械股份有限公司 关于公司产品获得二类医疗器械注册证的公告

Core Viewpoint - The company has received a medical device registration certificate for its endoscope cleaning workstation, which enhances its product offerings in the medical infection control sector [1][5]. Medical Device Registration Details - Product Name: Endoscope Cleaning Workstation [1] - Registration Number: Lu Xie Zhu Zheng 20252110546 [1] - Registered Entity: Shandong Xinhua Medical Instrument Co., Ltd. [1] - Registered Address: Xinhua Medical Technology Park, High-tech Industrial Development Zone, Zibo City, Shandong Province [1] - Production Address: No. 1 Jiuzhou Road, Baita Town, Boshan District, Zibo City, Shandong Province (Contract Manufacturing) [1] - Structure and Composition: The workstation consists of various components including ultrasonic tank, cleaning tank, rinsing tank, disinfection tank, final rinsing tank, and drying platform for soft and hard endoscopes [1][2]. Product Characteristics - The endoscope cleaning workstation features an integrated design for efficient cleaning and disinfection processes, utilizing imported PMMA polymer materials for durability and ease of cleaning [4]. - It includes an intelligent control system for multi-tank independent operation, automating standard processes such as enzyme washing and ultrasonic oscillation [4]. - The workstation ensures thorough cleaning with high-pressure flushing and features a gas dilution discharge system to eliminate harmful vapors [4]. - It meets national standards for endoscope cleaning and disinfection, with real-time monitoring and data traceability capabilities [4]. Impact on Company Performance - The introduction of the new generation endoscope cleaning workstation expands the company's technological layout in medical infection control, enhancing its core competitiveness in the disinfection field [5].