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Disposable flow adjustable precision filter infusion set with needle - NMPA Registration 国械注准20173144383

Access comprehensive regulatory information for Disposable flow adjustable precision filter infusion set with needle 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20173144383 and owned by SHENGGUANG MEDICAL Instrument Co., Ltd.. The device was approved on July 14, 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.

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Class III
国械注准20173144383
Disposable flow adjustable precision filter infusion set with needle
一次性使用流量微调式精密过滤输液器 带针
NMPA Registration Number: 国械注准20173144383
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Intended Use
English

It is suitable for single-use gravimetric infusion solutions that require microflow adjustment and precise filtration in the clinic.

中文

适用于临床上需要微流量调节、精密过滤的一次性使用重力式输液。

Device Classification
Device Class
Class III
Model Specifications
WT-YN-2 、WT-YN-3、WT-YN-5、WT-YY-2、WT-YY-3、WT-YY-5、WT-NN-2、WT-NN-3、WT-NN-5、WT-NY-2、WT-NY-3、WT-NY-5. 所配静脉输液针规格为:0.36、0.4、0.45、0.5、0.55、0.6、0.7、0.8、0.9、1.1、1.2mm.
WT-YN-2 、WT-YN-3、WT-YN-5、WT-YY-2、WT-YY-3、WT-YY-5、WT-NN-2、WT-NN-3、WT-NN-5、WT-NY-2、WT-NY-3、WT-NY-5。所配静脉输液针规格为:0.36、0.4、0.45、0.5、0.55、0.6、0.7、0.8、0.9、1.1、1.2mm。
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20173144383
Approval Date
July 14, 2022
Expiry Date
September 05, 2027
Registrant
Name
SHENGGUANG MEDICAL Instrument Co., Ltd.
圣光医用制品股份有限公司
Province/Region
Henan
河南
Address
East section of Longshan Avenue, Hao County
郏县龙山大道东段
Production Facility
Production Address
平顶山市郏县龙山大道东段
Structure and Composition
English

Disposable flow fine precision filtration infusion device The needle is composed of flow fine adjustment precision filtration infusion set and intravenous infusion needle. Intravenous needles are optional. Among them, the flow fine-tuning precision filtration infusion device is composed of a stopper trocar protective sleeve, a cork trocar, an air intake (optional), a connector (optional), a dropper, a dropper, a pipeline, a scale flow regulator, a stop clip or switch (optional), a injection (optional), a liquid filter, an outer cone joint, and a protective cap (optional); The IV needle is composed of a protective sleeve, a needle tube, a needle handle (single wing/double wing), a hose, and a connecting seat. The pore size of the filter membrane of the chemical filter is: 2μm, 3μm, 5μm. The product is sterilized by ethylene oxide.

中文

一次性使用流量微调式精密过滤输液器 带针是由流量微调式精密过滤输液器、静脉输液针组成。静脉输液针为可选配件。其中流量微调式精密过滤输液器是由瓶塞穿刺器保护套、瓶塞穿刺器、进气件(可选)、连接件(可选)、滴管、滴斗、管路、刻度流量调节器、止流夹或开关(可选)、注射件(可选)、药液过滤器、外圆锥接头、保护帽(可选)组成;静脉输液针是由保护套、针管、针柄(单翼/双翼)、软管、连接座组成。药液过滤器的滤膜孔径为:2μm、3μm、5μm。产品经环氧乙烷灭菌。

Additional Information
Remark
原注册证编号:国械注准20173664383
Appendix
产品技术要求