Original Title: Official: These CE Certifications Are Invalid (List of Certification Bodies Attached) Concern Source: Cypress Blue Apparatus 1. Two types of CE certification are invalid According to the official micro-news of Shanghai Supervisory Bureau on April 14, Shanghai Supervisory Bureau recently found that some individuals and organizations, for the purpose of making profits, released information such as "CE certification can be handled quickly" through network platforms and short messages. These individuals and organizations charge high fees by inducing enterprises to entrust their agents with so-called "CE certificates" which are actually invalid or unnecessary,KN95 Mask with Fast Shipping, which not only causes economic losses to enterprises, but also seriously disrupts the order of the certification market. For medical masks and personal protective masks,Quickly Delivery Disposable Protective Clothing, the following two types of documents are not CE certificates. The first category is for medical masks (not sterile) (Disposable medical protective mask), and the relevant supporting documents are marked with "CE document review (CE Documentation Review)", which is not a certification certificate. The second category is for personal protective masks (Disposable daily productive mask), Antivirus Disposable Mask with CE Certificate ,Medical Disposable Coverall, which are marked with "certificate of conformity (Certificate of Compliance)" or similar words, but the body issuing the certificate is not the notified body of the European Union. Or although it is a notified body, the scope of authorization does not include PPE regulations. Expand the full text The Shanghai Municipal Bureau of Supervision also said that a large number of certificates for mask products (personal protective masks and medical masks (non-sterile)) issued to domestic mask manufacturers in the name of ENTE CERTIFICAZIONE MACCHINE SRL companies have recently appeared in the market. The documents are marked with the company's "ECM" mark and CE mark. It was found that the ENTE CERTIFICAZIONE MACCHINE SRL was not an authorized notified body in the field of (EU) 2016/425 (PPE) and could not carry out CE certification for personal protective masks. 2. List of CE certification institutions, published by the State Municipal Supervision Bureau Recently, the State Municipal Supervision Bureau issued the "Guidelines for Market Certification of Masks and Other Epidemic Prevention Supplies Exported to the European Union and the United States", which provides information guidelines for the export of masks to the European Union. According to the guidelines, the European Union divides masks into two categories according to their use: medical masks and personal protective masks. Medical masks: Medical masks shall be affixed with CE mark in accordance with EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR), and the corresponding standard is EN14683. According to the aseptic or non-aseptic status of mask products, the conformity assessment mode is also different. (1) Sterile medical masks: must be CE certified by an authorized notified body. (2) Non-sterile medical masks: The enterprise only needs to make a CE self-declaration of conformity, and does not need to be certified by a notified body. After preparing the corresponding documents and test reports, you can complete the declaration of conformity by yourself. Personal protective mask: The personal protective mask is not a medical device, but it must meet the requirements of the European Union Personal Protective Equipment Regulation EU2016/425 (PPE). The authorized notified body carries out CE certification and issues certificates. The corresponding standard is EN149. At the same time, the State Municipal Supervision Bureau has also published a list of certification bodies with CE certification capability for epidemic prevention products such as masks in China,Full Body Disposable Coverall, as well as a list of institutions that can carry out certification of medical device management system (ISO13485), as follows: List of certification bodies with CE certification capability for epidemic prevention products such as masks in China: List of institutions that can carry out medical device management system (ISO13485) certification in China: Is the title of "the world's largest ventilator manufacturer" changed? GM mass produces ventilators! Handheld Ultrasound Accuro FDA Approved! 100% accuracy! For the first time in the United States, saliva is approved to detect novel coronavirus! The first domestic surgical robot was registered on the Science and Technology Innovation Board! Nine adverse events! Boston Scientific Angiography Catheter Faces Level One Recall! Return to Sohu to see more Responsible Editor:. zjyuan-group.com