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欧普康视:关于获得医疗器械注册证的公告
Zheng Quan Ri Bao· 2025-09-18 13:36
Core Viewpoint - The company, Opcon Vision, has received a medical device registration certificate for its "medical ultrasonic nebulizer" from the Anhui Provincial Drug Administration, marking a significant regulatory milestone for the company in the medical device sector [2]. Group 1 - The medical ultrasonic nebulizer has been classified as a Class II medical device [2]. - The registration certificate number is 20252080196, indicating official approval for the product [2].
9月18日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-18 10:30
Group 1 - Shudao Equipment's subsidiary signed a construction contract worth 24.68 million yuan for a hydrogen fuel cell manufacturing base project [1] - Zhongliang Technology received a land acquisition compensation of 30 million yuan from the government [2] - Palm Holdings won a bid for a high-standard farmland construction project in Lankao County, with a contract value of 433 million yuan, accounting for 14.12% of the company's audited revenue for 2024 [3] Group 2 - Changchun Yidong's subsidiary received a government subsidy of 2.85 million yuan, which is 122.78% of the company's audited net profit for the last fiscal year [4] - Wuzhou Transportation successfully issued 200 million yuan in medium-term notes with an interest rate of 2.10% [5][6] - Tiandi Source's subsidiary plans to apply for a trust loan of up to 500 million yuan from related parties [8] Group 3 - Tiandi Source's subsidiary acquired a residential land use right in Xi'an for 2.015 billion yuan [9] - Opcon Vision received a medical device registration certificate for its ultrasonic nebulizer [11] - Jingjiawei announced the resignation of its vice president due to personal reasons [13] Group 4 - Fulinh Precision's subsidiary received a prepayment of 1.5 billion yuan from CATL for securing lithium iron phosphate material supply [15] - Yunzhu Technology's subsidiary received a government subsidy of 20.12 million yuan [16] - Kehua Bio's ferritin test kit received a medical device registration certificate [17] Group 5 - Jinghua Pharmaceutical's medical sodium alginate wound dressing received a medical device registration certificate [18] - Lingwei Technology established a wholly-owned subsidiary with a registered capital of 1 million yuan [19] - Sanwei Co. won a bid for concrete sleeper procurement projects worth 158 million yuan [20] Group 6 - Shanghai Pharmaceuticals' Nicardipine tablets passed the consistency evaluation for generic drugs [21] - Lushan New Materials increased its idle fund management limit to 750 million yuan [24] - Huayi Technology announced the retirement of a core technical staff member [25] Group 7 - Yingli Environment plans to use up to 300 million yuan of idle raised funds for cash management [30] - Yong'an Forestry plans to develop a national reserve forest project in Putian, Fujian, with an estimated investment of 154 million yuan [32] - Xinyuan Technology's shareholders plan to reduce their holdings by up to 3.18% of the company's shares [60]
欧普康视(300595.SZ)取得一项医疗器械注册证
智通财经网· 2025-09-18 08:43
Core Viewpoint - The company, Opple Vision (300595.SZ), has received a Class II medical device registration certificate for its "medical ultrasonic nebulizer" from the Anhui Provincial Drug Administration [1] Group 1 - The medical ultrasonic nebulizer has completed registration and is now officially recognized as a medical device [1]
欧普康视取得一项医疗器械注册证
Zhi Tong Cai Jing· 2025-09-18 08:40
Core Viewpoint - The company, Opcon Vision (300595.SZ), has received a Class II medical device registration certificate for its "Medical Ultrasonic Nebulizer" from the Anhui Provincial Drug Administration [1] Company Summary - The company has successfully completed the registration process for its medical ultrasonic nebulizer, indicating progress in its product development and regulatory compliance [1]
欧普康视(300595.SZ):医用超声雾化器获得医疗器械注册证
Ge Long Hui A P P· 2025-09-18 08:36
Core Viewpoint - The company, Opcon Vision (300595.SZ), has received the Medical Device Registration Certificate from the Anhui Provincial Drug Administration for its "Medical Ultrasonic Nebulizer," marking a significant milestone in its product development and regulatory approval process [1]. Group 1 - The approved product is designed for nebulizing liquid medications for inhalation therapy, targeting patients who require such treatments [1]. - The applicable areas for the product include the oral mucosa, nasal cavity, skin around the eyes, and the cornea [1]. - The device is intended for use in medical institutions such as clinics and hospitals, as well as in home settings [1].
欧普康视:医用超声雾化器获得医疗器械注册证
Ge Long Hui· 2025-09-18 08:30
Core Viewpoint - The company Ophthalmic Technology (300595.SZ) has received the Medical Device Registration Certificate for its "Medical Ultrasonic Nebulizer" from the Anhui Provincial Drug Administration, marking a significant regulatory approval for its product [1] Group 1: Product Details - The approved product is designed for nebulizing liquid medications for inhalation therapy [1] - It is applicable for treating patients with conditions requiring nebulization, targeting areas such as oral mucosa, nasal passages, periorbital skin, and cornea [1] - The product is intended for use in medical institutions (such as clinics and hospitals) as well as in home settings [1]
欧普康视(300595) - 关于获得医疗器械注册证的公告
2025-09-18 08:22
欧普康视科技股份有限公司 关于获得医疗器械注册证的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 欧普康视科技股份有限公司(以下简称"公司")于近日收到安徽省药品监 督管理局颁发的《中华人民共和国医疗器械注册证》(注册证编号:皖械注准 20252080196),公司的"医用超声雾化器"已完成注册并获得第二类医疗器械 注册证。现将具体信息公告如下: 证券代码:300595 证券简称:欧普康视 公告编号:2025-080 一、注册产品基本情况 1、注册人名称:欧普康视科技股份有限公司 2、注册人住所:合肥市高新区望江西路 4899 号 3、生产地址:合肥市高新区望江西路 4899 号 1#C 楼 1 层 4、产品名称:医用超声雾化器 5、注册分类:Ⅱ类 6、型号、规格:OPKS-SYY-I 7、结构及组成:由主机、雾化杯、加热管路组成,主机由超声波发生器、 超声薄膜、送风装置、调节和控制系统组成。 8、适用范围:用于对液态药物进行雾化,供患者吸入治疗使用。 9、注册证编号:皖械注准 20252080196 10、审批部门:安徽省药品监督管理局 11、注册证有 ...
欧普康视:公司的主营产品角膜塑形镜属于三类医疗器械
Zheng Quan Ri Bao Wang· 2025-09-17 09:45
Group 1 - The core viewpoint of the article highlights that the National Health Commission has recognized orthokeratology lenses as an effective method for myopia prevention and control in its recently published guidelines [1] - The company's main product, orthokeratology lenses, is classified as a Class III medical device and has been in use for over 20 years, gaining recognition from both experts and users [1] - The number of users for the orthokeratology lenses has exceeded 2 million, indicating a strong market presence and acceptance [1]
调研速递|欧普康视接受多家线上投资者调研 透露业务调整与新品进展要点
Xin Lang Zheng Quan· 2025-09-15 13:30
Core Insights - The company participated in an online investor meeting on September 15, 2025, discussing business adjustments and new product developments [1][2]. Group 1: Business Adjustments - The decline in revenue from nursing products was attributed to the restructuring of online business and the cessation of partnerships with certain clients, leading to decreased distribution income [3]. - The company is exploring entry into the CPO, smart glasses, and brain-machine interface sectors through equity participation, having already established a partnership with Raytheon and Huiding for smart glasses, with the joint venture registered [3]. Group 2: New Products - Inquiries regarding the launch timeline for new products such as AI glasses and atropine eye drops were addressed, indicating that AI glasses are in preliminary preparation while atropine is still in phase III clinical trials, with disclosures to follow regulatory requirements [3]. - The company has launched scleral lenses in the first half of the year, aiming to capture a portion of the high-end frame market, although specific pricing strategies were not disclosed [3]. Group 3: Stock Repurchase - The company stated that any matters related to stock repurchase and cancellation would be disclosed in accordance with regulations, emphasizing that the meeting did not involve any undisclosed significant information [3].
欧普康视(300595) - 2025年9月15日投资者关系活动记录表
2025-09-15 11:46
Group 1: Financial Performance and Business Adjustments - The company's subsidiary adjusted its online business structure, leading to a decline in nursing product revenue due to the cessation of cooperation with certain clients [1] - The scleral lens was launched in the first half of the year, aiming to capture part of the high-end frame market [2] Group 2: Product Development and Future Plans - The joint venture with Thunder and Huiding has completed business registration, but products have not yet been officially launched [2] - The atropine eye drops are still in phase three clinical trials [2] Group 3: Strategic Initiatives and Market Positioning - The company is exploring acquisition or investment opportunities in high-tech firms producing CPO or smart glasses [1] - There is no public discussion on specific pricing strategies for scleral lenses, including potential reductions to 3900 yuan per pair [2] Group 4: Shareholder Engagement and Stock Management - Any stock repurchase plans will be disclosed according to regulations [2] - The activity did not involve any undisclosed significant information [2]