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二类医疗器械即毁式一次性使用无菌阴道扩张器取得产品注册证Class II Medical Device-- Instant-Destruction Type Disposable Sterile Vaginal Dilator – Obtaining Registration Certificate

产品名称: 即毁式一次性使用无菌阴道扩张器 
企业名称: 宁波**医疗器械有限公司
执行标准: 产品技术要求
适用范围: 产品为一次性使用产品,供妇产科作阴道诊察用。
规格型号: 详见附表
注册证号: 浙械注准2019218****
批准日期: 2019-11-25
有效期至: 2024-11-24
产品性能结构及组成: 产品由上叶、下叶、档位调节杆、即毁式卡勾和手柄组成。

Product name: instant-destruction type disposable sterile vaginal dilator

Enterprise: Ningbo XXX Medical Device Co., Ltd.

Standards:  technical requirements for the product

Application scope: the product is for single use in examination per vagina for obstetrics & gynaecology.

Specifications & models: see the attached table.

Registration Certificate No.: 浙械注准2019218XXX

Approving date: 2019-11-25

Valid until: 2024-11-24

Structure & composition: the product consists of upper & lower blades, a grade-adjusting lever, an instant-destruction hook and a handle.


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