We produce and export directly to more than 100 countries. Our products include infusion sets, syringes, medical components including drip chamber, roller clamp, cap, Luer lock connector, etc.

2025年1月21日 · Liaoning Kangyi Medical Equipment Co., Ltd was founded in 1994 and is one of the leading manufacturers within the health care industry in the Chinese province of Liaoning.

IV sets are categorized based on their application, considering factors such as suitability for adults or children, compatibility with individuals allergic to natural rubber, the appropriateness of PVC-made infusion sets for specific medications, and the potential impact of UV exposure on drugs that may be sensitive to it, posing potential harmf...

td文件中，比较重要的一个文件就是ifu, 这一块是咨询老师比较头疼的地方，客户往往有的都是中文的，符合nmpa要求的使用说明书，这就要求咨询老师（或者制造商认证专员）进行有效的翻译和转换。

无论您申请哪个国家/地区，医疗器械 IFU 都是 CE 标志 文件的重要组成部分。 确保您的监管部门概述了每个地区的要求，因为要求不同。 新的欧洲法规有一套结构和自己独特的术语。 A、 设备的名称或商品名称。 B、 制造商名称、注册商号或注册商标及其注册营业地点的地址。 C、 在适用的情况下，表明该设备包含或包含： ——药用物质，包括人类血液或血浆衍生物。 ——人类来源的组织或细胞，或其衍生物。 ——如果设备是无菌供应的，则说明其无菌状态和灭菌方法 …

医疗器械使用电子说明 (eIFU)的法规 RGULATION (EU) 2021/2226 已在欧盟官方杂志上公布。 本法规废除了之前的欧盟委员会Regulation 207/2012要求，以适应 MDR (EU)2017/745 要求。 实施RGULATION (EU) 2021/2226概述了医疗器械使用说明 (IFU)可以以电子形式而非纸质形式提供。 欧盟委员会决定采用该法规，以减少医疗器械行业的环境负担和成本，同时保持或提高安全水平。 注：关于电子使用说明的REGULATION (EU) 2021/2226不适用于体外诊断医疗器械 (IVD),也 …

At KMed, we take immense pride in the infusion sets we produce. While some may view it as a traditional product lacking innovation, we see it as an opportunity to continuously improve and cater...

IFU documents contain sterilization and cleaning instructions, and other product information. All Acumed IFUs are multilingual. Use the form below to search for the most current IFUs.

Founded in 1994, KANGYI Medical is an infusion sets manufacturer in China. Our infusion sets are produced with requirements to CE and ISO 13485 according to REGULATION (EU) 2017/745. The factory occupies 20,000 sqm, with 8,000 square meters of …

To locate the exact version of the IFU for your product, use the second search option, by product Lot Number. To locate the Reference Part Number or Order Number, look on the product label for this symbol: Please select your country/region first, …