喜報！3N獲批首個創(chuàng)新醫(yī)療器械三類證—「鏡凈GP」硬性接觸鏡護理消毒儀
3N Eyecare獲批中國首個接觸鏡護理有源設備NMPA創(chuàng)新醫(yī)療器械三類證，開創(chuàng)接觸鏡護理領域的新紀元！
3N Eyecare Pioneers New Era in Contact Lens Care with China’s First NMPA-Certified Class III Innovative Medical Device
【中國· 蘇州，2025年5月13日】近日，3N Eyecare自主研發(fā)的全球首創(chuàng)「鏡凈GP」硬性接觸鏡護理消毒儀，正式通過國家藥品監(jiān)督管理局（NMPA）創(chuàng)新醫(yī)療器械三類認證（注冊證編號：國械注準20253160887），成為中國接觸鏡護理有源設備首個獲此認證的創(chuàng)新醫(yī)療器械。該認證不僅標志著我國在接觸鏡護理技術領域?qū)崿F(xiàn)從跟跑到全球領跑的歷史性跨越，更向世界展示了中國醫(yī)療科技的硬核創(chuàng)新實力。
[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.
「世界級技術突破」
電泳解離技術重構硬鏡護理
「World-Class Breakthrough」
Elepy? Electrophoretic Dissociation Redefines Lens Care
作為全球硬性接觸鏡護理領域的創(chuàng)新型產(chǎn)品，「鏡凈GP」搭載3N Eyecare自主研發(fā)的電泳解離Elepy?技術，突破傳統(tǒng)化學清潔局限，開創(chuàng)有源的智能化護理范式：The 「ReO2 GP」 system incorporates 3N Eyecare’s proprietary Elepy? technology, which replaces traditional chemical cleaning with an intelligent, physics-based approach:
Elepy?是「鏡凈GP」硬性接觸鏡護理消毒儀的核心專利技術，它利用蛋白質(zhì)在電場中帶電泳動的特性，讓其在電場作用下定向脫離鏡片，再通過“電化學解離”的作用原理，解離生理鹽水產(chǎn)生含氯消毒溶液，可以進一步分裂蛋白質(zhì)肽鍵，將大分子蛋白打散成小分子，更利于電場力牽引蛋白質(zhì)，達到高效除蛋白的功能。且含氯溶液可以破壞病菌遺傳物質(zhì)，達到滅活病菌的作用。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：
標準模式可實現(xiàn)70%除蛋白率，強效模式可實現(xiàn)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 殺菌消毒：
對細菌，真菌，病毒，棘阿米巴包囊等微生物都有非常好的殺滅效果。
Disinfection:
Eliminates bacteria, fungi, viruses, and Acanthamoeba cysts with clinical-grade efficacy.
03 零化學添加：
僅需配合0.9%無菌氯化鈉溶液使用，避免傳統(tǒng)護理方式刺激性成分殘留，安全無刺激。Chemical-Free：
Uses only 0.9% sterile saline—no harsh chemicals or preservatives.
04 操作便捷：
操作流程含兩檔模式，分別為15分鐘快速殺菌除蛋白的標準模式（每日使用）與30分鐘深度除蛋白的強效模式（每周至少一次），兩種模式給予了硬性接觸鏡的日常護理可靠又易上手的解決方案，在保證清潔效率的基礎上，減少了手揉搓頻率，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.
「循證醫(yī)學，直擊痛點」
并發(fā)癥風險降低，用戶依從性提升
「Precision Solutions」Tackling Core Challenges
3N Eyecare將電泳解離Elepy?技術應用于硬性接觸鏡的護理領域，針對臨床痛點，讓患者實際獲益，以儀器設備搭載電泳解離Elepy?這項創(chuàng)新技術的形式，為硬性接觸鏡護理的智能化臨床實踐路徑夯實重要基礎，也讓世界見證了中國創(chuàng)新醫(yī)療技術的無限潛力。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.從實際意義的角度出發(fā)，3N 提供的硬性接觸鏡護理解決方案，是對傳統(tǒng)護理模式的顛覆性革新，它不僅提高了清潔效率，顯著降低了因手動揉搓導致的鏡片磨損和并發(fā)癥風險，更因其便捷的操作方式，提高了患者的依從性，具有重要的臨床推廣價值。
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：
現(xiàn)有護理技術中，無論是日常護理還是周期性護理，均能達到卓越的除蛋白和消毒殺菌功效，尤其是每周的強效模式，它的除蛋白率數(shù)據(jù)是現(xiàn)有護理技術中最高水平的展現(xiàn)。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 依從性高：
安全高效地除蛋白和殺菌，一直是困擾硬性接觸鏡配戴者的難題，3N硬性接觸鏡護理方案打破了常規(guī)需要護理人員（孩子、家長等）熟練掌握揉搓方法和熟悉各類護理產(chǎn)品不混合使用的弊端，為接觸鏡配戴用戶提供了更簡便快捷的選擇，從而提高了依從性。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：
只需生理鹽水沖洗鏡片后，鏡片放入鏡片夾，根據(jù)儀器提示進行智能化操作，有效解放雙手，進一步提高了患者依從性。
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 無毒副作用：
僅搭配0.9%無菌氯化鈉溶液使用，無論是護理還是沖洗液均使用0.9%無菌氯化鈉溶液，安全無刺激，不含防腐劑。
Chemical-Free Safety:
Exclusively using 0.9% sterile saline for both cleaning and rinsing ensures irritation-free care with no preservatives.
05 患者滿意度高：
在國內(nèi)外多家權威眼科醫(yī)院相繼開展了上市前臨床試驗，受試者對該設備的可接受度高，舒適度評價好，患者需求得到了更好的滿足。只需要一臺設備搭配鹽水，無需記得多種護理產(chǎn)品，混淆使用，可以極大減少患者的護理憂慮，提升患者對于角塑的接受度。
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.
「中國創(chuàng)新，世界共享」
推動全球接觸鏡護理新發(fā)展
「China’s Innovation, Shared Globally」
Advancing Contact Lens Care Worldwide
Elepy?技術的出現(xiàn)，不僅解決了傳統(tǒng)護理方式殘留沉淀、操作繁瑣的臨床痛點，更通過標準化流程顯著提升了用戶依從性，為降低角膜缺氧、感染性角膜炎等并發(fā)癥風險提供了集全面、科學、安全為一體的解決方案。
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.
「鏡凈GP」硬性接觸鏡護理消毒儀作為全球首創(chuàng)暨中國首個獲批NMPA創(chuàng)新三類證的硬鏡護理設備，標志著國產(chǎn)醫(yī)療器械在硬鏡護理領域的自主創(chuàng)新能力邁入國際前沿。不僅確立了中國在全球接觸鏡護理領域完全創(chuàng)新技術開創(chuàng)者的地位，更以循證醫(yī)學支撐的臨床研究成果為技術背書，推動接觸鏡護理行業(yè)從傳統(tǒng)的護理模式向有源的智能護理模式轉(zhuǎn)型升級。未來，3N Eyecare將持續(xù)為全球數(shù)億接觸鏡配戴用戶構建更安全、便捷的護理生態(tài)。
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.
關于3N Eyecare
About 3N Eyecare
3N Eyecare，作為植根中國、布局全球的創(chuàng)新型科技企業(yè)，始終聚焦專業(yè)的接觸鏡護理產(chǎn)品，其通過歷時十年的潛心探索，成功研發(fā)電泳解離Elepy?技術，該技術以卓越的接觸鏡除蛋白與殺菌消毒功效，讓接觸鏡配戴者們遠離病毒、細菌等困擾，享受安全、舒適的配戴體驗。3N立足全球接觸鏡用戶角度，致力于提供更安全、更便捷、更智能的全方位接觸鏡護理解決方案。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.
