CE和FDA 双认证:博辉瑞进医用外科口罩(Medical Surgical Mask)中英文产品介绍


作者:本站编辑    发布日期:2020-12-30

南德 TÜV CE证书编号:No.G2S 101395 0003 Rev.00

TÜV SÜD CE certificate:No.G2S 101395 0003 Rev.00


医疗器械注册证编号:京械注准20202140240

China Class II Medical Device Registration Certificate: 京械注准20202140240


产品分类:无菌/非无菌(Type: Sterile/Non-sterile


佩戴方式耳挂式/绑带式

Wearing Method: Ear-hang/Head-mounted


适用范围:适用于医务人员或相关人员的基础防护,以及在有创操作过程中阻止体液和喷溅物传播的防护。

Typical applications:Medical Surgical Mask is suitable for basic protection of medical staff and relavant personnel, as well as protection against the spread of body fluids and splashes during invasive procedures.


医用外科口罩

Medical Surgical Mask



耳挂式




绑带式










主要材质:采用经典SMS三层结构设计,外层阻水抗湿,内层透气吸水,中间层为25g/㎡熔喷布,为防止病原体微生物、体液、颗粒物等直接透过提供物理屏障。


Main material: It adopts the classic SMS three-layer structure design. The outer layer is water and moisture resistant, the inner layer is breathable and absorbance. The middle layer is 25g/㎡ melt-blown fabric, providing a phsical barrier to prevent the direct transmission of pathogenic microorganisms, body fluids, particles, etc..

 

过滤效率:可过滤平均直径3微米的细菌气溶胶,过滤效果95%以上。

Filtration efficiency: It can filter bacterial aerosols with an average diameter of 3 microns. Filtration efficiency is greater than 95%.

 

抗血液穿透:外层抗血液穿透压力超过120mmHg。

Fluid Pressure: Fluid pressure of the outer layer is greater than 120mmHg.







医用外科口罩-产品性能


医用外科口罩-证书明细



 医用外科口罩 FDA 510K,K202029 



 ISO  13485证书 

ISO  13485 QMS Certificate 


 CE证 

CE Certificate 



 无菌符合性声明DOC 

Sterile DOC 


 非无菌符合性声明 DOC

Non-sterile  DOC 

 欧盟登记注册 

EU registration Certificate 


 EN14683检测报告 

 EN 14683 Standard Report 


 Reach报告 

Reach Report 



 生物学ISO 10993报告 

Biological ISO 10993 Report 


 ASTM F2100-检测报告 

 ASTM F2100 Report 


 YY 0469 注册检报告 

 ASTM YY0469 Test Report 


 医疗器械出口销售证明 

 Export sales Certificate 

 企业海关出口资质 

 Customs qualification 



 中华人民共和国注册证 

China Certificate 



 医疗器械生产许可证 

 Production License  




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