CE certificate:
CE certificate is to enter the EU countries market»pass», our company radiation protection clothing and accessories have been sold overseas countries.
ISO9001 quality system certificate:
ISO9001 standard is the International Organization for Standardization (ISO) in 1987 issued in the world on the common quality management and quality assurance on a series of standards, all certified enterprises, in the management system integration has reached the international standard, Indicating that enterprises can continue to provide customers with stable and satisfactory products.
FDA certification:
The FDA’s management of medical devices is carried out through the Center for Devices and Radiological Health(CDRH), which supervises the production, packaging, and distribution of medical devices to comply with the law.
The range of medical devices ranges from medical gloves to cardiac pacemakers, all under the supervision of the FDA. According to medical uses and possible harm to the human body, the FDA classifies medical devices into categories I, II, and III. The more categories are supervised. If the product is a novel invention that does not exist on the market, the FDA requires manufacturers to conduct rigorous human experiments with convincing medical and statistical evidence to demonstrate the effectiveness and safety of the product.
Inspection Report:
1. Institute of radiation medicine, China’s Shandong Academy of medical science inspection report.
[NOTE]:When buying radiation protective products, be sure to look for products with inspection reports. The test report requires that all the parameters of the product must conform to the relevant regulations of the state.
Medical device filing certificate:
Medical device filing certificate is necessary to produce medical radiation protective clothing and accessories, If the manufacturer does not have a medical device filing certificate, he is not qualified for production or the product is not recognized.
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