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 medical device registration certificates for two products, the surgical shadowless lamp and the thoracic and abdominal endoscope, which are expected to enhance its product offerings and competitive edge in the medical device market [1][6]. Group 1: Surgical Shadowless Lamp - Product Name: Surgical Shadowless Lamp [1] - Registration Number: Lu Xie Zhu Zheng 20252010721 [1] - Features: Ultra-thin butterfly design, high color rendering medical LED light source, multiple modes for clinical needs [2] - Applicable Scope: Designed for surgical lighting in medical institutions [1] - Approval Date: November 27, 2025 [1] - Validity Period: Until November 26, 2030 [1] - Market Context: 101 companies in the same industry have obtained similar product registration certificates [1]. Group 2: Thoracic and Abdominal Endoscope - Product Name: Thoracic and Abdominal Endoscope [8] - Registration Number: Lu Xie Zhu Zheng 20252060702 [8] - Features: Dual-mode confocal design, ultra-clear imaging, and durable sapphire lens [5] - Applicable Scope: Used for examination and observation in thoracic and abdominal surgeries [4] - Approval Date: November 19, 2025 [4] - Validity Period: Until November 18, 2030 [4] - Market Context: 13 companies in the same industry have obtained similar product registration certificates [4]. Group 3: Impact on Company Performance - The surgical shadowless lamp meets diverse clinical lighting needs, enriching the company's surgical product line [6] - The thoracic and abdominal endoscope complements the company's medical fluorescence endoscope imaging system and minimally invasive surgical instruments, enhancing its product variety and core competitiveness [6].