喜报！3N获批首个创新医疗器械三类证—「镜净GP」硬性接触镜护理消毒仪

3N Eyecare获批中国首个接触镜护理有源设备NMPA创新医疗器械三类证，开创接触镜护理领域的新纪元！

3N Eyecare Pioneers New Era in Contact Lens Care with China’s First NMPA-Certified Class III Innovative Medical Device

 

【中国· 苏州，2025年5月13日】近日，3N Eyecare自主研发的全球首创「镜净GP」硬性接触镜护理消毒仪，正式通过国家药品监督管理局（NMPA）创新医疗器械三类认证（注册证编号：国械注准20253160887），成为中国接触镜护理有源设备首个获此认证的创新医疗器械。该认证不仅标志着我国在接触镜护理技术领域实现从跟跑到全球领跑的历史性跨越，更向世界展示了中国医疗科技的硬核创新实力。

[Suzhou, China | May 13, 2025] — 3N Eyecare’s groundbreaking 「ReO2 GP」Rigid Contact Lens Care, the world’s first active care device for rigid contact lenses, has received Class III Innovative Medical Device certification (Registration No.: Guo Xie Zhun 20253160887) from China’s National Medical Products Administration (NMPA). This milestone not only marks China’s leap from follower to global leader in contact lens care technology but also showcases the nation’s cutting-edge innovation in medical technology.

 

「世界级技术突破」

电泳解离技术重构硬镜护理

「World-Class Breakthrough」

Elepy® Electrophoretic Dissociation Redefines Lens Care

 

作为全球硬性接触镜护理领域的创新型产品，「镜净GP」搭载3N Eyecare自主研发的电泳解离Elepy®技术，突破传统化学清洁局限，开创有源的智能化护理范式：The 「ReO2 GP」 system incorporates 3N Eyecare’s proprietary Elepy® technology, which replaces traditional chemical cleaning with an intelligent, physics-based approach:

Elepy®是「镜净GP」硬性接触镜护理消毒仪的核心专利技术，它利用蛋白质在电场中带电泳动的特性，让其在电场作用下定向脱离镜片，再通过“电化学解离”的作用原理，解离生理盐水产生含氯消毒溶液，可以进一步分裂蛋白质肽键，将大分子蛋白打散成小分子，更利于电场力牵引蛋白质，达到高效除蛋白的功能。且含氯溶液可以破坏病菌遗传物质，达到灭活病菌的作用。Elepy® is the core patented tech of the 「ReO2 GP」 rigid contact lens care and disinfection device. It uses the characteristic of protein electrophoresis in an electric field to detach proteins from lenses. Then, via electrochemical dissociation, it splits saline into a chlorine-based disinfectant. This solution breaks protein bonds, turning large proteins into smaller ones for easier removal, effectively achieving efficient protein removal. Also, the chlorine solution destroys pathogens' genetic material, inactivating them.

 

01 除蛋白效果：

标准模式可实现70%除蛋白率，强效模式可实现95%深度除蛋白率。

Protein Removal:

Standard Mode-70% protein removal (daily use).Enhanced Mode-95% deep protein removal (weekly use).

 

02 杀菌消毒：

对细菌，真菌，病毒，棘阿米巴包囊等微生物都有非常好的杀灭效果。

Disinfection:

Eliminates bacteria, fungi, viruses, and Acanthamoeba cysts with clinical-grade efficacy.

 

03 零化学添加：

仅需配合0.9%无菌氯化钠溶液使用，避免传统护理方式刺激性成分残留，安全无刺激。Chemical-Free：

Uses only 0.9% sterile saline—no harsh chemicals or preservatives.

 

04 操作便捷：

操作流程含两档模式，分别为15分钟快速杀菌除蛋白的标准模式（每日使用）与30分钟深度除蛋白的强效模式（每周至少一次），两种模式给予了硬性接触镜的日常护理可靠又易上手的解决方案，在保证清洁效率的基础上，减少了手揉搓频率，增加了操作便捷性。

User-Friendly Design:

The device features two user-friendly cleaning modes: a 15-minute Daily Care Mode for quick disinfection and protein removal, and a 30-minute Weekly Deep-Clean Mode for thorough maintenance. Both modes ensure efficient cleaning while minimizing manual scrubbing, simplifying rigid contact lens care into a hassle-free routine.

 

「循证医学，直击痛点」

并发症风险降低，用户依从性提升

「Precision Solutions」Tackling Core Challenges

 

3N Eyecare将电泳解离Elepy®技术应用于硬性接触镜的护理领域，针对临床痛点，让患者实际获益，以仪器设备搭载电泳解离Elepy®这项创新技术的形式，为硬性接触镜护理的智能化临床实践路径夯实重要基础，也让世界见证了中国创新医疗技术的无限潜力。3N Eyecare applies its Elepy® electrophoretic dissociation technology to rigid contact lens care, targeting clinical challenges to deliver real-world patient benefits. By integrating this innovation into a dedicated device, the company lays a critical foundation for intelligent clinical practices in lens care while showcasing the boundless potential of China’s innovative medical technologies.从实际意义的角度出发，3N 提供的硬性接触镜护理解决方案，是对传统护理模式的颠覆性革新，它不仅提高了清洁效率，显著降低了因手动揉搓导致的镜片磨损和并发症风险，更因其便捷的操作方式，提高了患者的依从性，具有重要的临床推广价值。

From a practical perspective, 3N’s rigid contact lens care solution represents a revolutionary innovation over traditional methods. It not only enhances cleaning efficiency and significantly reduces risks of lens abrasion or complications caused by manual scrubbing but also improves patient compliance through its user-friendly design, offering substantial clinical value for widespread adoption.

 

01 功效卓越：

现有护理技术中，无论是日常护理还是周期性护理，均能达到卓越的除蛋白和消毒杀菌功效，尤其是每周的强效模式，它的除蛋白率数据是现有护理技术中最高水平的展现。Superior Efficacy:

Among existing care technologies, 3N’s solution achieves exceptional protein removal and disinfection performance in both daily and weekly routines. Its enhanced weekly mode demonstrates the highest protein removal rate currently available in the industry.

 

02 依从性高：

安全高效地除蛋白和杀菌，一直是困扰硬性接触镜配戴者的难题，3N硬性接触镜护理方案打破了常规需要护理人员（孩子、家长等）熟练掌握揉搓方法和熟悉各类护理产品不混合使用的弊端，为接触镜配戴用户提供了更简便快捷的选择，从而提高了依从性。Enhanced Compliance:

Safe and efficient protein removal and sterilization have long challenged rigid lens wearers. 3N’s system eliminates the need for caregivers (e.g., children, parents) to master manual scrubbing techniques or manage multiple products, offering a simpler solution that boosts user adherence.

 

03 操作智能：

只需生理盐水冲洗镜片后，镜片放入镜片夹，根据仪器提示进行智能化操作，有效解放双手，进一步提高了患者依从性。

Smart Operation:

After rinsing lenses with saline, users simply place them in the holder and follow automated prompts—a hands-free process that further improves compliance.

 

04 无毒副作用：

仅搭配0.9%无菌氯化钠溶液使用，无论是护理还是冲洗液均使用0.9%无菌氯化钠溶液，安全无刺激，不含防腐剂。

Chemical-Free Safety:

Exclusively using 0.9% sterile saline for both cleaning and rinsing ensures irritation-free care with no preservatives.

 

05 患者满意度高：

在国内外多家权威眼科医院相继开展了上市前临床试验，受试者对该设备的可接受度高，舒适度评价好，患者需求得到了更好的满足。只需要一台设备搭配盐水，无需记得多种护理产品，混淆使用，可以极大减少患者的护理忧虑，提升患者对于角塑的接受度。

High Patient Satisfaction:

Pre-market trials at leading global eye hospitals confirmed strong user acceptance and comfort ratings. The single-device, saline-only approach reduces care anxiety and improves acceptance of orthokeratology by eliminating complex product regimens. 

 

「中国创新，世界共享」

推动全球接触镜护理新发展

「China’s Innovation, Shared Globally」 

Advancing Contact Lens Care Worldwide

 

Elepy®技术的出现，不仅解决了传统护理方式残留沉淀、操作繁琐的临床痛点，更通过标准化流程显著提升了用户依从性，为降低角膜缺氧、感染性角膜炎等并发症风险提供了集全面、科学、安全为一体的解决方案。

The Elepy® technology addresses critical clinical challenges of traditional care methods, such as residue buildup and complex routines, while its standardized protocols significantly boost user compliance. This innovation provides a comprehensive, science-backed solution to reduce risks of complications like corneal hypoxia and infectious keratitis, combining safety and efficacy into one system.

 

「镜净GP」硬性接触镜护理消毒仪作为全球首创暨中国首个获批NMPA创新三类证的硬镜护理设备，标志着国产医疗器械在硬镜护理领域的自主创新能力迈入国际前沿。不仅确立了中国在全球接触镜护理领域完全创新技术开创者的地位，更以循证医学支撑的临床研究成果为技术背书，推动接触镜护理行业从传统的护理模式向有源的智能护理模式转型升级。未来，3N Eyecare将持续为全球数亿接触镜配戴用户构建更安全、便捷的护理生态。

As the world’s first and China’s inaugural NMPA Class III Innovative Device-certified rigid contact lens care system, the 「ReO2 GP」Contact Lens Care marks China’s emergence as a global leader in ophthalmic innovation. This milestone not only positions China as a pioneer in fully autonomous contact lens care technology but also accelerates the industry’s shift toward evidence-based, intelligent solutions. Backed by clinical research, 3N Eyecare is driving the transition from outdated manual practices to active, smart care systems. Moving forward, 3N will continue building safer, simpler care ecosystems for hundreds of millions of lens wearers worldwide.

 

关于3N Eyecare

About 3N Eyecare

3N Eyecare，作为植根中国、布局全球的创新型科技企业，始终聚焦专业的接触镜护理产品，其通过历时十年的潜心探索，成功研发电泳解离Elepy®技术，该技术以卓越的接触镜除蛋白与杀菌消毒功效，让接触镜配戴者们远离病毒、细菌等困扰，享受安全、舒适的配戴体验。3N立足全球接触镜用户角度，致力于提供更安全、更便捷、更智能的全方位接触镜护理解决方案。3N Eyecare, an innovative technology company headquartered in China with a global footprint, specializes in professional contact lens care solutions. After a decade of dedicated research, the company pioneered the Elepy® electrophoretic dissociation technology, which delivers exceptional protein removal and disinfection capabilities. This breakthrough empowers contact lens wearers to enjoy a safe, comfortable experience free from bacteria and viruses. Grounded in the needs of users worldwide, 3N is committed to advancing smarter, safer, and more convenient all-in-one contact lens care systems.