Qualification honor

Business  License

Business License

Registered capital:RMB 20 million yuan

Type of enterprise:Sino-foreign joint venture company

Business rangeThe second category of ward care equipment and apparatus; three types of physical therapy and rehabilitation equipment; the third category of low and medium pressure vessels, medical oxygen chamber, ship oxygen chamber, ship pressure vessel, diving pressurized cabinets, refrigeration equipment and related components , production, installation, maintenance; to provide repair of marine boilers, and sales of the company listed in the self-produced products

Institution:Yantai Zhifu District Market Supervision and Administration Bureau
DateDecember 22, 2015

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

Medical equipment business license

Medical equipment business license

Business range:Ⅱ, Ⅲ class:6826Physical therapy and rehabilitation equipment 6854Operating room, emergency room, treatment room equipment and apparatus  Ⅱclass:6856Ward care equipment and apparatus

Institution:Shandong Province Food and Drug Administration

Date:January 18, 2016

Effective date:November 19, 2017

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

Date:November 14, 2013

Effective date:November 13, 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

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. 

Date:August 12, 2013

Effective date:August 11, 2017

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 0287-2003 idt ISO 13485:2003 requirements, idiopathic this card.

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

DateJune 19, 2015

Effective dateJune 18, 2018

Weapon Equipment Quality System Certificate

Weapon Equipment Quality System Certificate

Upon review, Yantai Hongyuan Oxygen Industry Co., Ltd., according to the requirements of national military standards GJB9001B-2009, and passed the quality system certification.The quality system applies to: 1.6MPa following land pressurized cabin design, development, production, installation and serviceThe first category of pressure vessels, the second category of low and medium pressure vessel design, development, production and services.

InstitutionWeapon Equipment Quality System Certification Committee

DateJune 13, 2017

Effective dateJune 12, 2020

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

Date:September 4, 2014

Effective date:January 15, 2018

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