豫械注准20222181080

Disposable sterile vaginal dilator

一次性使用无菌阴道扩张器
Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.·Class II·NMPA·Approved May 30, 2022
Device classification
Device class
Class II
Model specifications
Model: shaft rotation type, push and pull type Specifications: large, medium, small
型号:轴转式、推拉式 规格:大号、中号、小号
Approval department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration information
Registration number
豫械注准20222181080
Approval date
May 30, 2022
Expiry date
May 29, 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
Intended use
English

It is used for vaginal examination in obstetrics and gynecology.

中文

供妇产科作阴道诊察用。

Structure and composition
English

This product is mainly composed of upper leaf, lower leaf and handle.

中文

本产品主要由上叶、下叶和手柄组成。

Additional information
Remark
原注册证编号:豫械注准20172660188本注册证生效日期:2022年5月30日
About this record

Access comprehensive regulatory information for Disposable sterile vaginal dilator 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20222181080 and owned by Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.. The device was approved on May 30, 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.