All series of Hetaida thermometers have obtained ISO 13485 certification
ISO13485 Chinese is called "Medical Device Quality Management System for Regulatory Requirements." Since medical devices are special products for saving lives, healing the wound, preventing and curing diseases, it is not enough to standardize the general requirements of the ISO9000 standard. For this reason, the ISO organization issued ISO13485: The 1996 version of the standard (YY/T0287 and YY/T0288) puts forward special requirements for the quality management system of medical device manufacturers, which has played a good role in promoting the quality of medical devices to achieve safety and effectiveness.
All Hetaida infrared thermometers have won the National Certification of Measuring Apparatus (CPA).
The CPA mark is a special mark for the type approval certificate of measuring instruments. Imported measuring instruments need to be approved by a technical institution authorized by the administrative department of measurement under the State Council, and the result of the appraisal shall be reported to the administrative department of measurement under the State Council for review by the technical institution undertaking the authentication. Upon examination, the metrological administrative department of the State Council shall issue the "Certificate of Type Approval for Imported Measuring Instruments of the People’s Republic of China" to the applicant, and allow the use of the CPA special mark and type approval of the imported measuring instruments of the People’s Republic of China on corresponding measuring instruments and packaging Numbering. The type approval of domestic measuring instruments refers to the recognition of whether the type of new measuring instruments meets the legal requirements. The type approval certificate issued by the metrological administrative department of the State Council can be used as a national general type and approved in the corresponding measuring instruments. And use the CPA special mark and number for the type approval of measuring instruments on the packaging.
The materials used in the Hetaida series products are all environmentally friendly and have been awarded the EU RoHS environmental protection certification, so consumers can use them with peace of mind.
RoHS is a mandatory standard formulated by the EU legislation, its full name is "Restriction of Hazardous Substances in Electrical and Electronic Equipment" (Restriction of Hazardous Substances). The standard has been officially implemented on July 1, 2006, mainly for regulating the material and process standards of electrical and electronic products, so that they are more conducive to human health and environmental protection.
Hetaida is one of the few domestic thermometer brands certified by the U.S. FDA, and the FDA registration number of Hetaida non-contact infrared thermometer is K171888.
The U.S. Food and Drug Administration (FDA) is part of the U.S. Department of State Health and Services Public Health Service, responsible for the management of all food, drugs, cosmetics and radiation instruments, it is also the earliest consumer protection agencies in the U.S. The FDA has a tremendous influence in the United States and the world, with "the patron saint of American health "It is also the first consumer protection agency in the United States.
Therefore, many manufacturers in the international are pursuing to obtain FDA certification as the highest honor and guarantee of product quality.
The infrared thermometer of Hetida has won the FDA certification, and the product performance has been recognized by international inspection agencies, so consumers can use it with confidence.