TÜV南德CE认证:博辉瑞进隔离衣BH500(Medical Protective Coverall BH500)


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


第一类医疗器械备案凭证:京大械备20200017号

China Class I Medical Device Record Certificate: 京大械备20200017号

适用范围:隔离衣-BH500用于医疗机构门诊、病房、检验室等作医生普通隔离。

Typical applications: Medical Protective Coverall-BH500 is used as a general isolation for medical staff in outpatient clinics, wards and labs of medical institutions.


隔离衣-BH500

Medical Protective Coverall BH500





主要材质:主原料采用68g/㎡高密度聚乙烯复合聚丙烯纺粘非织造布,表面进行二次覆膜处理,形成高强、加厚、抗湿、防穿透的隔离保护层,同时兼具有呼吸功能,保证医生的舒适度。


防静电性能材质经过抗静电处理,有效减少颗粒、微生物吸粘附。


防护性能有效防护颗粒物(第五类防护)及液体有限喷溅(第六类防护)。


隔离性能:通过有效过滤并阻挡空气中粉尘微粒、细菌等有害物质的渗入,保护医护人员的身体健康。


Main material: High-end PE coated spunbond non-woven materials of 68g/㎡ is used as main material. The material is subjected to secondary coating treatment on the surface of high-density polymer long-fiber non-woven fabric to form a high-strength, thickened, moisture-resistant, and penetration isolation protective layer.


Anti-static performance: The material is treated with anti-static treatment, which can effectively reduce the adsorption and adhesion of particles and microorganisms.


Protection performance: Effective protection against particles (Type 5 Protection) and limited liquid splashing (Type 6 Protection).


Isolation performance: Protect the health of medical staff by effectively filtering and blocking the infiltration of dust particles, bacteria and other harmful substances in the air.


隔离衣BH500-产品性能



隔离衣-BH500 证书明细


 ISO  13485证书 

ISO  13485 QMS Certificate 


 CE证 

CE Certificate 

隔离衣BH500-FDA 

 FDA Listing 


 第一类医疗器械备案凭证 

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 

 EN14126/Reach 检测报告 

 EN14126/Reach Report 



 EN 13982 检测报告 

 EN 13982 Test Report 

 EN 13982 检测报告 

 EN 13982 Test Report 

 ISO 16604 检测报告 

 ISO 16604 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 


 医疗器械生产许可证 

 Production License  



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