医疗感染控制
Search documents
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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-03 23:03
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].
新华医疗:公司产品内镜清洗工作站获得二类医疗器械注册证
Xin Lang Cai Jing· 2025-09-03 07:41
Core Viewpoint - The company has received a medical device registration certificate for its endoscope cleaning workstation, which will enhance its position in the medical infection control sector [1] Group 1: Company Developments - The company announced the receipt of the registration certificate from the Shandong Provincial Drug Administration for its endoscope cleaning workstation [1] - The product is designed for the cleaning and disinfection of flexible endoscopes and the cleaning of rigid endoscopes [1] - Obtaining this registration certificate will further expand the company's technological layout in the field of medical infection control [1] Group 2: Industry Impact - The new product will strengthen the hospital infection prevention and control system [1]
新华医疗产品获得二类医疗器械注册证
Zhi Tong Cai Jing· 2025-09-03 07:37
Core Viewpoint - Xinhua Medical (600587.SH) has received a medical device registration certificate from the Shandong Provincial Drug Administration for its new product, the endoscope cleaning workstation, which enhances its technology layout in the field of medical infection control [1] Group 1: Product Development - The endoscope cleaning workstation is designed for cleaning and disinfecting both flexible and rigid endoscopes, indicating a comprehensive approach to infection control [1] - The introduction of this next-generation product expands Xinhua Medical's offerings in the medical equipment sector, particularly in the disinfection and cleaning domain [1] Group 2: Market Positioning - The intelligent cleaning and disinfection solutions provided by the new workstation strengthen the hospital infection prevention and control system, offering multiple options for customers [1] - This product launch is expected to enhance the company's product matrix in medical devices, thereby solidifying its core competitiveness in the cleaning and disinfection field [1]