Recently, BSI British Standards Institution (British Standards Institution, referred to as: BSI) announced: According to the European Union Medical Device Regulation (MDR, EU 2017/745), Guilin HBM Health Protections Co., Ltd. (hereinafter referred to as “HBM Protections”) issued CE certification of medical device products under the new EU Medical Device Regulation (MDR).
The officially certified product is Medispo medical gloves, a brand of HBM Protections. This is not only the first medical device company in China to obtain the EU’s CE certification (MDR) certificate based on new trade rules, but also the first one in China’s latex industry to obtain this certification as manufacturer of latex gloves.
Previously, CE certification was the legal requirement of the European Union for the listing of medical device products, and it was also a certification for the safety and performance of medical device products. The current MDR is a new version of the regulations issued by the European Commission in line with the development of the medical device industry, which puts forward higher requirements for clinical evaluation and testing of products before they are marketed.
As we all know, BSI ranks first in the medical devices reviewed by all institutions in the world, and BSI has extremely high requirements on product risk control and product compliance. Because of the rapid development of the medical industry, it is highlighted that the previous management and control methods are not flexible enough, and it has been criticized in the EU market for many years. Therefore, the new trade rules based on MDR have greatly raised the threshold for entering the EU market.
As the first batch of enterprises in the latex industry and even China to obtain CE certification under the new rule system, HBM Protections has trained its team and consolidated the system after two years of hard work. Medispo Medical Gloves took the lead in obtaining the certification that complies with the new MDR regulations, indicating that it will be unrivaled in the European market and represent the entire Chinese latex enterprise to break out into the world.
MDR (European Union Medical Device Regulation)
Medispo, a global professional brand of medical Protections, is produced by Guilin HBM Health Protections Co., Ltd. (referred to as HBM Protections). It has been a brand for more than ten years and is sold well in more than 50 countries and regions around the world.
Since its inception, Medispo has been committed to the innovation of applied technology in the medical surgical glove industry and the medical cover industry. With the industry’s advanced production and control system, including 100,000-level cleanliness packaging workshop, high-precision inspection and control system, it is the master of the global medical surgical gloves and the innovation driver of medical masks in China.
Various products of Madispo have been tested and certified by Wuhan Institute of Virology, Chinese Academy of Sciences, National Leather Quality Center, and the famous ARDL laboratory in the United States. In terms of sales, Medispo has been leading the export of medical surgical gloves in China for many years with its cost-effective advantage.
At present, under the Medispo brand, there are AQL 0.65 & AQL 1.0 & AQL 1.5 high-standard medical gloves, anti-virus gloves, double gloves, extended thick/Orthopedic gloves, ultra-thin/sensitive gloves, protein non-detectable gloves, examination gloves (with powder), examination gloves Gloves (powder-free), sterilization examination gloves (powdered), sterilization examination gloves (powder-free) and more than ten products.
The goal of Medispo medical gloves is to become the world’s largest brand of production capacity, to become the first brand of Chinese medical gloves, and to become the pride of China’s medical-grade gloves to the world.
Medispo medical masks are in line with the quality and innovation of medical surgical gloves. The upcoming anti-virus medical masks will be a revolution in the traditional medical mask industry.
NOTHING OR BETTER. This is the concept of Guilin HBM Protections, and it is also the growth direction of Madispo.
