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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版權所有北京博輝瑞進生物科技有限公司 京ICP備16026579號 (京)-非經營性-2017-0030 京公網安備 11011502006176號 (京)網藥械信息備字(2022)第00096號