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Disposable sterile urinary catheters - NMPA Registration 豫械注准20222140723

Access comprehensive regulatory information for Disposable sterile urinary catheters 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20222140723 and owned by Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.. The device was approved on June 16, 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 II
豫械注准20222140723
Disposable sterile urinary catheters
一次性使用无菌导尿包
NMPA Registration Number: 豫械注准20222140723
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Intended Use
English

It is suitable for clinical catheterization of patients.

中文

适用于临床对患者实施导尿手术时使用。

Device Classification
Device Class
Class II
Model Specifications
Model: single cavity, double cavity, three cavity; Specifications: Fr6, Fr8, Fr10, Fr12, Fr14, Fr16, Fr18, Fr20, Fr22, Fr24, Fr26, Fr28, Fr30
型号:单腔、双腔、三腔;规格:Fr6、Fr8、Fr10、Fr12、Fr14、Fr16、Fr18、Fr20、Fr22、Fr24、Fr26、Fr28、Fr30
Approval Department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration Information
Registration Number
豫械注准20222140723
Approval Date
June 16, 2022
Expiry Date
March 25, 2027
Registrant
Name
Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.
河南省健琪医疗器械有限公司
Province/Region
Henan
河南
Address
Dingluan Industrial Zone, Changyuan City
长垣市丁栾工业区
Production Facility
Production Address
长垣市丁栾工业区
Structure and Composition
English

This product consists of basic configuration and optional configuration. Basic configuration: disposable sterile urinary catheter, spreading and optional configuration: medical cotton balls, disposable drainage bags, medical tweezers, disposable medical rubber examination gloves, iodophor cotton balls, medical degreasing gauze blocks, hole towels, item boxes, disposable dispensing syringes, sponge brushes, disposable sterilized rubber surgical gloves, PE examination gloves, hemostatic forceps, disposable medical pads, self-adhesive wound stickers, webbing, urinary catheter clamps, pins, test tubes, body surface catheter fixation devices, lubricants, Consists of water for injection (not for injection).

中文

本产品由基本配置和选配置组成。基本配置:一次性使用无菌导尿管、铺布和选用配置:医用棉球、一次性使用引流袋、医用镊、一次性使用医用橡胶检查手套、碘伏棉球、医用脱脂纱布块、洞巾、物品盒、一次性使用配药用注射器、海绵刷、一次性使用灭菌橡胶外科手套、PE检查手套、止血钳、一次性医用垫、自粘式伤口护贴、织带、导尿管夹、别针、试管、体表导管固定装置、润滑剂、注射用水(非注射用)组成。

Additional Information
Remark
本文件与“一次性使用无菌导尿包(注册证编号:豫械注准20222140723)”医疗器械注册证共同使用。
Changes
注册人住所由“长垣县丁栾工业区”变更为“长垣市丁栾工业区”。生产地址由“长垣县丁栾工业区”变更为“长垣市丁栾工业区”。