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      TüV南德CE認證:博輝瑞進隔離衣BH500(Medical Protective Coverall BH500)


      作者:本站編輯    發布日期:2021-01-04

      南德 TüV CE證書編號:No.G2S 101395 0003 Rev.00


      TüV SüD CE certificate:No.G2S 101395 0003 Rev.00


      第一類醫療器械備案憑證:京大械備20200017號

      China Class I Medical Device Record Certificate: 京大械備20200017號

      適用范圍:隔離衣-BH500用于醫療機構門診、病房、檢驗室等作醫生普通隔離。

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


      隔離衣-BH500

      Medical Protective Coverall BH500





      主要材質:主原料采用68g/㎡高密度聚乙烯復合聚丙烯紡粘非織造布,表面進行二次覆膜處理,形成高強、加厚、抗濕、防穿透的隔離保護層,同時兼具有呼吸功能,保證醫生的舒適度。


      防靜電性能材質經過抗靜電處理,有效減少顆粒、微生物吸粘附。


      防護性能有效防護顆粒物(第五類防護)及液體有限噴濺(第六類防護)。


      隔離性能:通過有效過濾并阻擋空氣中粉塵微粒、細菌等有害物質的滲入,保護醫護人員的身體健康。


      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.


      隔離衣BH500-產品性能



      隔離衣-BH500 證書明細


       ISO  13485證書 

      ISO  13485 QMS Certificate 


       CE證 

      CE Certificate 

      隔離衣BH500-FDA 

       FDA Listing 


       第一類醫療器械備案憑證 

      China Certificate 


       無菌符合性聲明 DOC 

      Sterile DOC 

       非無菌符合性聲明 DOC  

      Non-sterile DOC  

       歐盟登記注冊 

      EU registration Certificate 

       EN14126/Reach 檢測報告 

       EN14126/Reach Report 



       EN 13982 檢測報告 

       EN 13982 Test Report 

       EN 13982 檢測報告 

       EN 13982 Test Report 

       ISO 16604 檢測報告 

       ISO 16604 Test Report  


       醫療器械出口銷售證明 

       Export sales Certificate 


       企業海關出口資質 

       Customs qualification 


       醫療器械生產許可證 

       Production License  



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