Views: 0 Author: Site Editor Publish Time: 2023-11-15 Origin: Site
Medtrue Enterprise Co., Ltd. is a specialized OEM of medical and health care products, adhering to the principle of ‘Professional takes you to satisfaction’. We apply ourselves to offer better service to customers with our abundant experience since 1994 in this market, under the system ISO13485:2003.
Specifically, the main products include hospital equipment, medical instruments, health & home care products, medical disposable products, surgical dressings, laboratory products, education products, pharmaceutical materials and chemical products.
Excellent Service, Competitive Prices and Prompt Delivery, we are now looking forward to even greater cooperation with overseas customers based on mutual benefits. Please feel free to contact us for more information.
The OEMs of our company have all passed CE attestation. The quality and production management of the product meet with ISO13485 medical device quality management system, MDD93/42/EEC and the requirements of Europe harmony standard.
2.1 General Information
Disposable Medical Face Masks are made by cutting, becoming slice, heat joining, finishing and packing etc. The main material is PP non-woven, the material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff, they don't have any peculiar smell, other matters and primary colour. In a word, they are desirable sanitation materials. They have enough strength and good waterproof. They offer a credible barrier for medical personnel and can effectively block liquid splash which is often taken place in operation. The products are used in a convenient way, the cost is cheap, and they have good ventilation, and can be stored in a long period.
2.2 Product Picture
2.3 Model: MT59002001～MT59002052
Statement: Our Product is consistency with OEM Product except the label. And the labels see MT/CE 43-06 <Label and Language>.
Disposable Medical Face Masks are used for medical personnel using in operation and persons visiting patients to wear, so they can block and prevent the body fluid, blood and secretion from the potential infectious sufferers.
4 Flow chart of production processes see “MT/CE 43 Annex 2”.
a) The product can be used only once, it should be used immediately after opening the package and destroyed afterwards.
b) The period of validity is five years from the date of manufacture, must use them in this period.
c) Do not use if inner packing is damaged; or the product is damp or moldy.
d) Store in a place where avoids high temperature, high humidity, and does not have corroding gases, should have good dryness and ventilation.
6 Production environment, package and sterilization
The production and assembly of all product parts and accessories are completed in relative clean workhouses which are in line with the requirements. Inner packing uses paper-plastic bag. And after large packing, all the products are sterilized by radiation for single use.
7 Classification of product
The products belong to the non-invasive, non-active, and are sterilized by radiation. According to MDD appendix IX classification rule 1, it is class I sterile medical device.
8 Conformity assessment route: Annex V.3 of MDD 93/42/EEC
9 Supplier information (including CE certificate) see “List of CE-labeled Products” (latest edition)
10 Manufacturer
Name: MEDTRUE ENTERPRISE CO., LTD.
Add: Room No.301-302, Hongpujiezuo Mansion, 186-1 JiangdongZhonglu Road, 210019, Nanjing, China
Tel: 0086-25-86652838 Fax: 0086-25-86650138
11 European Representative
Name: MedPath GmbH
Address: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany
Tel:+49(0)89 189174474 Fax:+49(0)89 5485 8884
