Disposable medical hydrogel eye patches
- Device class
- Class II
- Model specifications
- Type I, II, IIIⅠ型、Ⅱ型、Ⅲ型
- Approval department
- Henan Provincial Drug Administration河南省药品监督管理局
- Registration number
- 豫械注准20182140256
- Approval date
- December 22, 2022
- Expiry date
- June 03, 2028
- Name
- Henan Yadu Industrial Co., Ltd.河南亚都实业有限公司
- Province/Region
- Henan河南
- Address
- No. 234, Jianpuxi Road, Puxi District, Changyuan City长垣市蒲西区建蒲西路234号
- Production address
- 长垣市蒲西区建蒲西路234号
It is applied to the outside of the eyes of patients with general anesthesia or deep coma to prevent exposure keratitis by providing a relatively sealed, moist environment.
贴敷于全麻或深度昏迷病人的眼外部，通过提供相对密闭的潮湿环境，预防暴露性角膜炎。
Type I is composed of polyvinyl alcohol hydrogel and non-woven fabric and polyethylene film, which is divided into two pieces on the left and right; Type II is composed of polyvinyl alcohol hydrogel and non-woven fabric, polyethylene film and ear band, of which the ear band is composed of non-woven fabric or elastic material; Type III is composed of polyvinyl alcohol hydrogel and non-woven fabric, polyethylene film and ear band.
Ⅰ型由聚乙烯醇水凝胶和非织造布、聚乙烯薄膜组成，分为左右两片；Ⅱ型由聚乙烯醇水凝胶和非织造布、聚乙烯薄膜、耳带组成，其中耳带由非织造布或弹性材料组成；Ⅲ型由聚乙烯醇水凝胶和非织造布、聚乙烯薄膜、耳带组成。
- Remark
- 原注册证编号：豫械注准20182640256 本注册证自“2023年06月04日”生效
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Disposable medical hydrogel eye patches in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 豫械注准20182140256 and owned by Henan Yadu Industrial Co., Ltd.. The device was approved on December 22, 2022.
This page provides complete registration details including registrant information, province location (Henan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.