Qualification honor

Business  License

Business License

Registered capital:RMB 2090.91 million yuan

Type of enterpriseOther limited liability companies

Business rangeTwo types of ward nursing equipment and apparatus and three kinds of physical therapy and rehabilitation equipment, pressure vessel, ship, hyperbaric chamber pressurized with air chamber, pressure vessel, ship chamber, saturation diving system development, production, repair, installation and technical services (valid to license), stainless steel display cabinets, storage cabinets lobster, box and refrigeration equipment and related parts of the development, production, repair, installation, technical services, repair of marine boiler, and sales company listed above self-produced products; import and export of goods and technologies.

Institution:Yantai Zhifu District Market Supervision and Administration Bureau
DateDecember 1, 2017

Design License of Special Equipment

Design License of Special Equipment

Upon review, the Yantai Hongyuan Oxygen Co., Ltd. approved the manufacture of D2 Class II low and medium pressure vessels and D1 class I pressure vessel

Institution:Quality and Technical Supervision Bureau of Shandong Province

Date:January 14, 2016

Medical equipment production license

Medical equipment production license

Production range:Ⅲ class:6826Physical therapy and rehabilitation equipment

Institution:Shandong Province Food and Drug Administration

Date:February 5, 2016

Effective date:June 16, 2020

Shandong famous brand

Shandong famous brand

Yantai Hongyuan Oxygen Industry Co., Ltd. of Hong Crown licensing of medical air pressurized oxygen chamber products, identified as the 2015 annual brand-name products in Shandong, idiopathic this certificate.

Institution:Province of Shandong Province Quality and Brand Strategy Promotion Leading Group Office

Date:December 23, 2015

Registration changes of medical instruments

Registration changes of medical instruments

Product Name: medical air compression chamber. The registrant's residence change file.

InstitutionState Administration of food and Drug Administration

DateAugust 8, 2017

Medical Appliances Registgation Certificate

Medical Appliances Registgation Certificate

Product name:Medical air compression oxygen chamber

Structure and composition:The product is air pressurized medical hyperbaric chamber, by the cabin(Shell, door, observation window, safety valve), gas supply system, oxygen system, air conditioning systems, electrical systems, monitoring and control and intercom systems, console composition.The maximum working pressure is not more than 0.2MPa.Product specifications and structure diagram see product technical requirements.

Institution:State Food and Drug Administration

Date:November 4, 2016

Effective date:November 3, 2021

Manufactur License of Special Equipment

Manufactur License of Special Equipment

Upon review, Yantai Hongyuan Oxygen Co., Ltd. approved the manufacture of A1-class high-pressure vessels and A5-class medical oxygen chamber

Institution:Quality and Technical Supervision Bureau of Shandong Province

DateOctober 23, 2017

Effective date:November 13, 2021

Product Quality Certificate

Product Quality Certificate

GY series of medical air pressurized oxygen chamber, audited in line with the CMD product certification requirements of the implementation rules, idiopathic this card.

Institution:Beijing Hua Guang Certification of Medical Devices Co.,Ltd. 

DateJuly 21, 2017

Effective dateJuly 20, 2021

Quality System Certificate

Quality System Certificate

Upon review, Yantai Hongyuan Oxygen Co., Ltd. quality management system in line with: GB / T I9001-2008 idt ISO 9001: 2008 requirements, idiopathic this card.

Institution:Beijing Hua Guang Certification of Medical Devices Co.,Ltd. 

DateJune 19, 2015

Effective dateJune 18, 2018

 

Medical Equipment Quality System Certificate

Medical Equipment Quality System Certificate

Upon review, Yantai Hongyuan Oxygen Co., Ltd. quality management system in line with: YY/T 0287-2017 idt ISO 13485:2016 requirements, idiopathic this card.

Institution:Beijing Hua Guang Certification of Medical Devices Co.,Ltd. 

DateJune 19, 2015

Effective dateJune 18, 2018

ASME Certification

ASME Certification

Through the international authority of the audit, Yantai Hongyuan Oxygen Co., Ltd. has made the ASME certification。

Institution:The American Society of Mechanica Engineers

DateNovember 20, 2017

Effective date:January 15, 2021