Zhejiang Donghaixiang Medical Device Co., Ltd medical device product information

台州东海翔防护用品有限公司 产品简介 Product introduction of donghaixiang mask

目录 Contents 1) 1) 企业简介企业简介 Company profile Company profile 2) 2) 产片证书产片证书 Product certificate Product certificate 3) 3) 出口资质出口资质 export qualification export qualification 4) 4) 产品介绍及检测报告产品介绍及检测报告Test report and product introduction Test report and product introduction

企业基本情况 企业基本情况东海翔集团有限公司，是一家集化纤纺织印染、塑料、包装用品、熔喷无纺布、医疗器材等产业研发、制造、销售于一体的大型集团化企业。连续多年获得临海市“十佳标兵企业”, “十强企业” 等荣誉称号。公司十分重视产品品质、技术积累、技术创新，已累计取得80多项发明专利，是浙江省科学技术厅评定的“省级高新技术企业研究开发中心”企业，“东海翔”商标也被评定为中国驰名商标。台州东海翔防护用品有限公司是东海翔集团旗下专业生产医疗器械、防护用品的全资子公司，是商务部医疗物资生产制造白名单企业，通过ISO13485医疗器械质量管理体系,具备各类相关资质，获得欧盟CE、美国FDA认证，拥有40条智能化平面口罩生产线，和拥有24条N95防护口罩生产线，可研发、生产、销售医用外科口罩、医用一次性使用口罩、一次性使用口罩、 N95防护口罩等产品，并配置了全套口罩检测设备，可自主对各类型口罩进行检测。公司以生产让人民放心的口罩为己任，选用最优质的材料、采用最先进的设备、建立完善的质量管理体系，提供高品质的产品，守护用户的健康。

Company Profile Donghaixiang group company is incorporate textile dyeing、plastic、package、melt-blown nowoven、 medical equipment etc. of large group company. The company has been awarded "top ten enterprises" in linhai city for several years. The company attaches great importance to the quality of the product, technology accumulation, and technologi cal innovation. Currently we have obtained more than 80 invention patents.and the company has evaluated by t he Zhejiang Provincial Department of Science and Technology as “Provincial Hightech Enterprise Research and D evelopment Center”. The "Donghaixiang" trademark was also evaluated as a well-known trademark in China. Taizhoudonghaixiang protective products Co., Ltd. is a wholly-owned subsidiary of donghaixiang group specializing in the production of medical devices and protective articles. Through ISO13485 medical device quality management system.It is a white listen terprise of the Ministry of Commerce for the production and manufacture of medical materials. It has all kinds of relevant qualifications, obtained thecer tification of EUCE and FDA, and has 40 intelligent mask production lines.It has 24 N95 production equipment lines， It can develop, produce and sell medical surgical masks and disposable medical ports Masks, disposable masks, N95 protective masks and other products, and equipped with a full set of mask detection equipment, can independently test varioustypes of masks. The company takes the responsibility of people , selects the best quality materials, adopts themost advanced equipment, establishes a perfect quality management system, provides high-quality products and protects the health of users.

营业执照 营业执照 Business license Business license

医疗器械注册证 医疗器械注册证 Medical instrument Medical instrument registration certificate registration certificate

医疗器械生产许可证 Medical device production license

产品出口资质 Product export qualification

EAC豁免函

出口白名单 进入中国医药保健品进出口商会查询：http://www.cccmhpie.org.cn/Pub/6325/176485.shtml

ISO 13485:2016认证

生产车间 Production workshop

disposable medical masks 一次性使用医用口罩【【产品主要技术指标产品主要技术指标】】 • • • • • 非无菌/无菌三层强效过滤≥95% 呼气阻力＜40% 符合YY/T0969-2013,EN14683 TYPEI, TYPE II, ASTM F2100 LEVEL2,LEVEL3等标准，取得CE符合性声明，FDA等相关认证【口罩主要原材料】 • • • 阻水无纺布吸湿无纺布熔喷布东海翔一次性使用医用口罩使用手册

disposable medical masks 一次性使用医用口罩 Main technical indicators of the product】 Non-sterile/sterile 3 layer High Filter Efficiency≥95% Expiratory resistance＜40% Meet YY / t0969-2013, en14683, type I, type II, ASTM f2100, level2, level3 and other standards, and obtain CE declaration of conformity, FDA and other relevant certification • High Filter Efficiency≥95% • Expiratory resistance＜40% • Meet YY / t0969-2013, en14683, type I, type II, ASTM f2100, level2, level3 and other standards, and obtain CE declaration of conformity, FDA and other relevant certification 【【Main technical indicators of the product】】 Non-sterile/sterile 3 layer • • [main raw materials of mask] Water repellent non woven fabric Moisture absorption non woven fabric Melt blown fabric [main raw materials of mask] Water repellent non woven fabric Moisture absorption non woven fabric Melt blown fabric • • • Donghaixiang disposable medical mask manual

国标YY/T0969-2013检测报告- 医用 YY/T0969-2013 Standard Test Report

EN14683:2019TypeI欧盟标准检测报告 EU standard EN14683：2019 TypeI

EN14683:2019TypeII欧盟标准检测报告 EU standard EN14683：2019 TypeII

一次性使用医用口罩CE符合性申明 EC DECLARATION OF CONFORMITY(TYPE 2) 11

美标-BFE检测-Astm F2100 USA BFE TESTING ASTM F2100

美标-PFE检测-Astm F2100 USA PFE TESTING ASTM F2100

美标-防火级别-Astm F2100 USA FLAMMABILITY TESTING ASTM F2100

美标-检测报告-Astm F2100 L2 L3 USA SYNTHETIC BLOOD TESTING ASTM F2100 L2 L3

美国 FDA

产品包装信息- 一次性使用医用口罩 Product packaging information disposable medical maks

medical maks 医用外科口罩【【产品主要技术指标产品主要技术指标】】 • • • • • 非无菌/无菌三层强效过滤≥98% 呼气阻力＜40% 符合YY 0469-2011,EN14683 TYPE IIR, ASTM F2100 LEVEL2,LEVEL3等标准，取得CE符合性声明，FDA等相关认证【口罩主要原材料】 • • • 阻水无纺布吸湿无纺布熔喷布东海翔医用外科口罩使用手册

医用外科口罩 medical maks 【【Main technical indicators of the product】】 Non-sterile/sterile 3 layer High Filter Efficiency≥98% Expiratory resistance＜40% Meet YY 0469-2011, en14683, type IIR, ASTM f2100, level2, level3 and other standards, and obtain CE declaration of conformity, FDA and other relevant certification • • • • • [main raw materials of mask] Water repellent non woven fabric Moisture absorption non woven fabric Melt blown fabric • • • Donghaixiang medical mask manual

国标YY0469-2011检测报告- 医用外科 YY0469-2011 Standard Test Report

EN14683:2019TypeIIR欧盟标准检测报告 EU standard EN14683：2019 TypeIIR

医用外科口罩CE符合性申明 EC DECLARATION OF CONFORMITY(TYPE 2R)

美标-BFE检测-Astm F2100 USA BFE TESTING ASTM F2100

美标-PFE检测-Astm F2100 USA PFE TESTING ASTM F2100

美标-防火级别-Astm F2100 USA FLAMMABILITY TESTING ASTM F2100

美标-检测报告-Astm F2100 L2 L3 USA SYNTHETIC BLOOD TESTING ASTM F2100 L2 L3

美国 FDA

产品包装信息- 医用外科 Product packaging information medical maks

KN95防护口罩使用手册 【【产品主要技术指标产品主要技术指标】 • 五层 • 热风棉 • 阻水无纺布 • 吸湿无纺布 • 两层熔喷布 • 符合GB2626-2006，EN149等标准，获得欧洲CE和美国FDA认证】【【产品特点产品特点】 • 强透气性 • 防雾霾 • 防飞沫 • 防粉尘】

Kn95 respirator manual 【【Main technical indexes of products】 • Five floors • Hot air cotton • Water blocking nonwoven fabric • Hygroscopic nonwoven fabric • Two layer meltblown cloth • According to gb2626-2006, en149 and other standards, it has been certified by European CE and FDA 【【Product features】】 • Breathable • Anti-haze • Droplet proof • Dust proof 】

Zhejiang Donghaixiang Medical Device Co., Ltd medical device product information

Zhejiang Donghaixiang Medical Device Co., Ltd medical device product information

Presentation Transcript

Medical Device Development

Medical Device Localisation

Medical Device Vigilance

Medical Device Safety

Medical device donations

Medical Device Engineering

Medical Device Standards

Medical Device Management

Medical Device Labeling

C2C Medical Device Product Development

Medical Device Sector

Medical Device Training

MEDICAL DEVICE STERILIZATION

Medical Device Development

Medical Device Simulator

Medical Device Resources

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