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      TüV南德CE認證:博輝瑞進一次性醫用防護服-BH800(Medical Protective Coverall BH800)


      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


      第二類醫療器械注冊證:京械注準20202140241

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


      產品分類:無菌、非無菌

      Product Classification: Sterile/Non-sterile


      適用范圍:非無菌產品可用于隔離留觀病區(房)、隔離病區(房)醫護人員穿的職業防護衣。阻止來自患者的病毒隨空氣或液體向醫務人員傳播。

      無菌產品適用于隔離重癥監護病區(房)醫護人員穿的職業防護衣,阻止來自患者的病毒隨空氣或體液向醫務人員傳播。

      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.

      一次性醫用防護服-BH800

      Medical Protective Coverall BH800






      一次性醫用防護服-產品性能




      主要材質:采用78g/㎡復合型非織造布為原料,由一種或多種對病毒氣溶膠、含病毒液體等具有隔離作用的面料,經裁剪縫紉加工而成。


      防護性能:外覆防護服專用熱封膠帶,有效阻隔病毒、細菌、有害超細粉塵、體液血液噴濺。


      防靜電性能材質經過抗靜電處理,減少有害物質吸附。

       

      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.



      一次性醫用防護服BH800-證書明細


       ISO  13485證書 

      ISO  13485 QMS Certificate 


       CE證 

      CE Certificate 

      一次性醫用防護服BH800-FDA 

       FDA Listing 


       中華人民共和國醫療器械注冊證 

      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 

       EN 14126/Reach 檢測報告 

       EN 14126/Reach Report 

       EN 14605 檢測報告 

       EN 14605 Test Report 

       EN 14605 檢測報告 

       EN 14605 Test Report 

       AAMI PB70 報告 

       AAMI PB70 Report 

       ISO 16604 報告 

      ISO 16604 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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