Single-use Precision Filter Light-shielded Infusion Set - NMPA Registration 国械注准20173144380
Access comprehensive regulatory information for Single-use Precision Filter Light-shielded Infusion Set in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20173144380 and owned by SHENGGUANG MEDICAL Instrument Co., Ltd.. The device was approved on August 02, 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.
The light-shielding range of this product is 290-450nm, and it is suitable for the infusion of photosensitive drugs levofloxacin hydrochloride sodium chloride injection, cisplatin for injection, and dopamine hydrochloride injection.
本产品的避光范围为290-450nm，适用于光敏性药物盐酸左氧氟沙星氯化钠注射液、注射用顺铂、盐酸多巴胺注射液的输注。
This product is composed of cork trocar protective sleeve, cork trocarpator, air intake parts (optional), flow stop clamp (optional), pipeline, injection parts (optional), dropper, drop bucket, flow regulator, precision chemical filter, outer cone joint, outer cone joint protective cap (optional), infusion needle (optional). The infusion needle consists of a connecting seat, a hose, a needle shank, a needle tube, and a protective sleeve. The membrane pore size of the precision chemical filter is: 2μm, 3μm, 5μm. The product drop hopper, pipe and hose are double-layer structure, the inner layer is made of polyurethane elastomer (TPU), and the outer layer is made of polyvinyl chloride (PVC). The plasticizer used in the outer pipeline is DEHP, and the light barrier is ferric oxide. The spectral transmittance of the drip hopper and the pipeline pair of 290-450nm wavelength were 35% for the drop hopper ≤ and 15% for the catheter ≤. The product is sterilized by ethylene oxide and sterile.
本产品由瓶塞穿刺器保护套、瓶塞穿刺器、进气件（可选）、止流夹（可选）、管路、注射件（可选）、滴管、滴斗、流量调节器、精密药液过滤器、外圆锥接头、外圆锥接头保护帽（可选）、输液针（可选）组成。输液针由连接座、软管、针柄、针管、保护套组成。精密药液过滤器的滤膜孔径为：2μm、3μm、5μm。产品滴斗、管路、软管为双层结构，内层为聚氨酯弹性体（TPU）材质，外层为聚氯乙烯（PVC）材质。外层管路所用增塑剂为DEHP，避光剂为三氧化二铁。滴斗、管路对290-450nm波长光谱透光率分别为：滴斗≤35%，导管≤15%。产品经环氧乙烷灭菌，无菌。