TüV南德CE認證：博輝瑞進隔離衣-BH200（Isolation Gowns-BH200）

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

產品分類：無菌/非無菌

Product Classification: Sterile/Non-sterile

 

適用范圍：用于醫療機構門診、病房、檢驗室等作普通隔離。

Typical applications:

It is used for general isolation in outpatient clinics, wards, inspection rooms, etc. of medical institutions.

隔離衣-BH200

Isolation Gowns-BH200

隔離衣-BH200  產品性能

主要材質：采用覆PE膜無紡布為原料，隔離衣材質為覆PE膜非織造物，單位質量不低于40g/㎡。產品接縫處采用熱熔膠密封，采用反穿式罩衣結構，在衣領和腰部分別有頸帶和腰帶，用于收緊隔離衣，袖子處采用彈性或編織收口。

Protection performance:

Using the PE coated PP non-woven fabric as the raw material. Seams are covered by special heat sealing tape for extra protection. Isolation gown has neckband, waistband together with elastic or knitted cuff wrist as one piece structure.

隔離衣-BH200  證書明細

 ISO  13485證書 

ISO  13485 QMS Certificate 

 CE證 

CE Certificate 

 第一類醫療器械備案憑證

China Certificate 

 符合性聲明 DOC 

Non-sterile DOC  

 歐盟登記注冊 

EU registration Certificate 

 AAMI PB70 報告-Level 3 

 AAMI PB70 Report-Level 3 

 Reach 報告 

 Reach 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