Shanghai Sunland Industrial Co., Ltd is the top manufacturer of Personal Protect Equipment in China, with 20 years’experience. We are the Chinese government appointed manufacturer for government power,personal protection equipment , medical instruments,construction industry, etc. All the products get the CE, ANSI and related Industry Certificates. All our safety helmets use the top-quality raw material without any recycling material.
Difference between industrial grade and medical grade nitrile gloves
We provide exclusive customization of the products logo, using advanced printing technology and technology, not suitable for fading, solid and firm, scratch-proof and anti-smashing, and suitable for various scenes such as construction, mining, warehouse, inspection, etc. Our goal is to satisfy your needs. Demand, do your best.
Professional team work and production line which can make nice quality in short time.
The professional team provides 24 * 7 after-sales service for you, which can help you solve any problems
Non Sterile ,Surgical, Face ,Mask CE Marking, and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices.. Since it falls under Class 1, Non-Sterile ,Surgical Mask, can be self Certified as per MDD 93/42/EEC.
28/3/2020, · UPDATE: We have now published our plan and risk assessment for Phase 1 of reopening our office and permanent reopening of our laboratory; please see here for details and here for our Risk Assessment . Subsequent to our previous post regarding the ,CE Marking, of ,surgical masks, used to prevent the spread of the COVID-19 virus, the UK Regulatory Authorities have moved quickly to assist ...
2/4/2020, · Do Type IIR ,masks, need a ,CE mark, assuming they have passed all tests? EN says the requirements on the packaging are ‚only‘: Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face ,mask, is supplied.
Evaluation of ,surgical masks, in Europe In Europe, ,surgical masks, must wear a ,CE mark, and comply with the requirements defined in EN 14683: Medical face ,masks, - Requirements and test methods. The standard defines ,surgical masks, as follows: medical devices covering the mouth, nose, and chin provide a barrier that limits the passage of an infective agent between hospital staff and the patient.
Is ,CE marking, a requirement for medical face ,masks,? Yes. According to the Executive Order on Medical Devices, it is required that medical face ,masks, are ,CE, marked when they are advertised and sold within the European market and thus also in Denmark. The ,CE marking, is the manufacturer’s guarantee that the ,mask, complies with current EU legislation.
The National Health Institute and Confindustria Dispositivi Medici (the Italian Association of Medtech Companies) jointly developed a technical datasheet identifying essential requirements for the placing on the market of ,surgical masks, for medical use not bearing the ,CE marking, pursuant to Article 15 of Decree Law No. 18 of March 17, 2020, so-called Decree "Cura Italia".
There are four possible routes to ,CE mark, your product, split into two groups given the product’s type, i.e., if it’s sterile or not. Table 2. ,CE marking, routes of Class IIa Medical Devices. Class IIb Medical Devices. Here, we can include medical devices such as long-term corrective contact lenses, ,surgical, lasers, defibrillators, and others.
Surgical masks, are also included in this group. The basic standard that must be complied with in order to put the ,CE mark, on the ,surgical masks, is the TS EN 149 standard (Respiratory protective devices - Half ,masks, with filters for protection against particles - Properties, experiments and ,marking, standard).
CE marking, of ,surgical masks, involves the respect of many obligations indicated in the Medical Device Regulation (Council Regulation 2017/745 of 5 April 2017 concerning medical devices, OJ No L 117/1 of 2017-05-05). ,Surgical masks, for use in the US and the EEA conform to …