TÜV南德CE认证:博辉瑞进一次性医用防护服-BH800(Medical Protective Coverall BH800)


作者:本站编辑    发布日期:2021-01-04

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

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


第二类医疗器械注册证:京械注准20202140241

China Class II Medical Device Registration Certificate: 京械注准20202140241


产品分类:无菌、非无菌

Product Classification: Sterile/Non-sterile


适用范围:非无菌产品可用于隔离留观病区(房)、隔离病区(房)医护人员穿的职业防护衣。阻止来自患者的病毒随空气或液体向医务人员传播。

无菌产品适用于隔离重症监护病区(房)医护人员穿的职业防护衣,阻止来自患者的病毒随空气或体液向医务人员传播。

Typical applications:

Medical Protective Coverall-BH800(Non-sterile) is used to provide barrier and protection for the blood, body fluids, secretions, and particles in the air of patients with potential infection that the clinical medical staff come into contact with at work.

Medical Protective Coverall-BH800(Sterile)is used to provide barrier and protection for the blood, body fluids, secretions, and particles in the air of patients with potential infection that the intensive care unit staff come into contact with at work.

一次性医用防护服-BH800

Medical Protective Coverall BH800






一次性医用防护服-产品性能




主要材质:采用78g/㎡复合型非织造布为原料,由一种或多种对病毒气溶胶、含病毒液体等具有隔离作用的面料,经裁剪缝纫加工而成。


防护性能:外覆防护服专用热封胶带,有效阻隔病毒、细菌、有害超细粉尘、体液血液喷溅。


防静电性能材质经过抗静电处理,减少有害物质吸附。

 

Main material: Composite nonwoven fabric of 78g/㎡ is used as raw material, and it is made by cutting and sewing one or more fabrics that can isolate virus aerosols and virus-containing liquids.


Protection performance: Seams are covered with special heat-sealing tape for extra protection. The tape can effectively block viruses, bacteria, harmful ultrafine dust, and body fluids and blood splashes.


Anti-static performance: The material is treated with anti-static treatment, which can effectively reduce the adsorption of harmful substances.



一次性医用防护服BH800-证书明细


 ISO  13485证书 

ISO  13485 QMS Certificate 


 CE证 

CE Certificate 

一次性医用防护服BH800-FDA 

 FDA Listing 


 中华人民共和国医疗器械注册证 

China 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 

 EN 14126/Reach 检测报告 

 EN 14126/Reach Report 

 EN 14605 检测报告 

 EN 14605 Test Report 

 EN 14605 检测报告 

 EN 14605 Test Report 

 AAMI PB70 报告 

 AAMI PB70 Report 

 ISO 16604 报告 

ISO 16604 Report 


 医疗器械出口销售证明 

 Export sales Certificate 

 企业海关出口资质 

 Customs qualification 


 医疗器械生产许可证 

 Production License  




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