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.
Grade of sterile protective clothing
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
Address：No. 3888, Hutai Road, Baoshan District, Shanghai, China
Class IIa ,Medical Devices,. ,Medical devices, of class IIa could be such as surgical gloves, hearing aids, diagnostic ultrasound machines, etc. They usually constitute low to medium risk. Patients should use them for a short-term period, any less than 30 days. If you are a manufacturer of a class IIa ,medical device,, you will have to back up your ...
device, to enable that ,medical device, to achieve its intended purpose, should be subject to all MDACS documents as apply to the ,medical device, itself. For classification purposes an accessory may be classified as though it is a ,medical device, in its own right. While most software is incorporated into the ,medical device, itself, some is not. Provided
18/10/2018, · Some examples of assistive technologies are: Mobility aids, such as wheelchairs, scooters, walkers, canes, crutches 1, prosthetic ,devices,, and orthotic ,devices,. 2; Hearing aids to help people hear or hear more clearly. 3 Cognitive aids, including computer or electrical assistive ,devices,, to help people with memory, attention, or other challenges in their thinking skills. 3
The ,Medical Devices, Bureau of Health Canada recognizes four classes ,of medical devices, based on the level of control necessary to assure the safety and effectiveness of the ,device,. Class I ,devices, present the lowest potential risk and do not require a licence. Class II ,devices, require the manufacturer's declaration of ,device, safety and effectiveness, whereas Class III and IV ,devices, present a ...
16/1/2018, · ,Medical, Imaging Explained – The ,Different Types of Medical, Imaging Available and Their Uses In an ideal world, we’d be able to diagnose and treat patients without any harmful side effects. ,Medical, imaging remains one of the best ways to achieve that aim , being able to see what’s going on inside the body without the need for surgery or other invasive procedures.
Diagnostic ,medical, equipment and supplies help clinicians to measure and observe various aspects of a patient's health so that they can form a diagnosis. Once a diagnosis is made, the clinician can then prescribe an appropriate treatment plan.
The FDA has established the classification ,of medical devices, for 1700 different generic ,types, of ,devices, within its industry. The ,medical devices, are classified into 16 ,medical, specialities such as dental, ear, and throat ,devices,. The classification ,of medical devices, consists of: Class I, Class II, and Class III.
2/2/2018, · Here then, are the differences between the different ,medical device, classes: Class I ,Medical Devices,. A Class I ,medical device, are those ,devices, that have a low to moderate risk to the patient and/or user. Today, 47% ,of medical devices, fall under this category and 95% of these are exempt from the regulatory process.
Medical Device Medical Device, Coordination Group Document MDCG 2019-14 MDCG 2019-14 Explanatory note on MDR codes December 2019 This document has been endorsed by the ,Medical Device, Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a
What I am about to share with you is a guide to ,medical device, regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your ,medical device, will be classified by U.S. FDA, the European Commission, and Health Canada.Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to ...