Certified. Licensed. Audited.
RIMION operates under internationally recognized quality certifications, Chinese regulatory licenses and independent third-party audits — covering the design, development, manufacture and export of medical diagnostic X-ray tube assemblies.
International Certification
The globally recognized standard that certifies RIMION's quality management system and opens international market access.
ISO 13485:2016
RIMION holds ISO 13485:2016 certification (designated GB/T 42061-2022 in China) for the design and development, manufacture and service of medical diagnostic X-ray tube assemblies. The certification body is Beijing Hua Guang Certification of Medical Devices Co., Ltd.
Chinese Regulatory Licenses
Official licenses issued by Chinese regulatory authorities for the manufacture, distribution, export and safe handling of radiation-emitting medical devices.
Medical Device Production License
The Medical Device Production License is issued by the Guangdong Provincial Medical Products Administration for the manufacture of Class II medical imaging devices — specifically medical diagnostic X-ray tube assemblies. It is a legal prerequisite for medical device production in China.
Radiation Safety License
The Radiation Safety License is issued under the Law of the People's Republic of China on the Prevention and Control of Radioactive Pollution. It authorizes RIMION to produce, sell and use Class III radiation-emitting devices in full compliance with national safety regulations.
Class II Medical Device Operating Registration
RIMION holds a Class II Medical Device Operating Registration Certificate covering wholesale and retail operations of Class II medical imaging devices. This registration allows RIMION to distribute medical devices legally within China and directly support local customers.
NMPA Medical Device Registration Certificates
RIMION's medical diagnostic X-ray tube assemblies hold Medical Device Registration Certificates issued by the National Medical Products Administration of China (NMPA) through the Guangdong Provincial Medical Products Administration. Each registration authorizes use with compatible CT scanners for X-ray generation.
Medical Device Export Sales Certificate
The Medical Device Export Sales Certificate is issued by the Guangdong Medical Products Administration. It confirms that RIMION's medical diagnostic X-ray tube assemblies are approved for manufacture and sale in China and are officially authorized for export to international markets.
SGS Audit Report
RIMION has been independently audited by SGS (SGS-CSTC Standards Technical Services Co., Ltd.) — the world's leading inspection, verification, testing and certification company. The audit verified manufacturing capacity, export trade capacity, service capacity, quality control and R&D capability.
Corporate & Brand Credentials
Official corporate registration and intellectual property documentation that establish RIMION as a legal, branded manufacturer.
Business License
The Business License (营业执照) issued by the Zhuhai Market Supervision Administration confirms RIMION's legal status as a limited liability company authorized for the research, development, manufacture and sale of medical equipment. It is a foundational document required for all export transactions.
Trademark Registration Certificate
The RIMION trademark is officially registered with the China National Intellectual Property Administration (CNIPA) for medical diagnostic X-ray tube assemblies and related medical imaging devices. The trademark protects the RIMION brand across Class 10 medical device categories.
SGS-Verified Factory
Beyond certification, RIMION has undergone a full on-site audit by SGS covering every operational dimension — production workflow, quality control, export capacity, staff experience and R&D. This gives international buyers independently verified assurance before placing an order.
What These Certifications Mean to You
Why each certification matters when you choose RIMION as your CT X-ray tube supplier.
Quality Assurance
ISO 13485 certifies that every RIMION tube is designed, manufactured and tested under a controlled quality management system — from raw material traceability to 100% factory testing before shipment.
Legal Compliance in China
The Medical Device Production License and Class II Operating Registration confirm that RIMION is legally authorized to manufacture, sell and distribute medical imaging devices in China — no gray-market supply, no unlicensed production.
International Market Access
The Medical Device Export Sales Certificate confirms that RIMION products meet international market requirements — simplifying customs clearance, tenders and procurement worldwide.
Third-Party Verified
Independent SGS audit gives buyers verified assurance of RIMION's manufacturing capacity, quality control and export capability — confirmed by a globally recognized inspection and certification company.
Radiation Safety
The Radiation Safety License confirms that RIMION meets China's national requirements for producing, selling and using radiation-emitting devices — protecting operators, patients and service personnel throughout the product lifecycle.
Quality Control Behind Every Tube
The processes that ensure every RIMION tube meets the same standard as the one before it.
Intelligent Aging Training
Every tube undergoes intelligent aging training before shipment — simulating continuous clinical exposure and high/low load switching. This screens and eliminates potential defects in advance.
100% Factory Testing
Each RIMION tube is 100% tested at the factory before packaging. Testing covers vacuum integrity, focal spot alignment, anode balance and electrical parameters — all recorded against the tube's serial number.
Raw Material Traceability
Full traceability from tungsten rhenium powder and alloy components to the finished assembly. Every raw material batch is identified, tested and linked to the tubes it produced — a core ISO 13485 requirement.
Automated Welding & Sealing
Fully automated intelligent welding for critical connection parts — ensuring vacuum sealing consistency, structural strength and long-term stability under high voltage and high temperature conditions.
High-Vacuum Packaging
Each tube is sealed in high-vacuum protective packaging, with custom foam housing to prevent mechanical stress during transport. Packaging is designed for air freight and international shipping.
Certification Questions
Common questions from procurement teams, distributors and tender reviewers.
Is RIMION ISO 13485 certified?
Yes. RIMION holds ISO 13485:2016 certification (also designated GB/T 42061-2022 in China) for the design and development, manufacture and service of medical diagnostic X-ray tube assemblies. The certification body is Beijing Hua Guang Certification of Medical Devices Co., Ltd.
Does RIMION hold a Medical Device Production License?
Yes. RIMION holds a Medical Device Production License issued by the Guangdong Provincial Medical Products Administration, covering the manufacture of Class II medical imaging devices (medical diagnostic X-ray tube assemblies).
Are RIMION CT tubes registered with the NMPA?
Yes. RIMION CT X-ray tube assemblies hold Medical Device Registration Certificates from the National Medical Products Administration of China (NMPA), issued through the Guangdong Provincial Medical Products Administration.
Does RIMION hold a Medical Device Export Sales Certificate?
Yes. RIMION holds a Medical Device Export Sales Certificate issued by the Guangdong Medical Products Administration, authorizing the export of its medical diagnostic X-ray tube assemblies.
Does RIMION hold a Radiation Safety License?
Yes. RIMION holds a Radiation Safety License issued by the Zhuhai Ecology and Environment Bureau, authorizing the production, sale and use of Class III radiation-emitting devices.
Is RIMION registered for the sale and distribution of medical devices?
Yes. RIMION holds a Class II Medical Device Operating Registration Certificate covering wholesale and retail operations of Class II medical imaging devices.
Has RIMION been audited by an independent third party?
Yes. RIMION has been independently audited by SGS (SGS-CSTC Standards Technical Services Co., Ltd.). The audit verified the company's manufacturing capacity, export trade capacity, service capacity, quality control and R&D capability.
Can I request copies of RIMION certificates for a tender or procurement process?
Yes. RIMION provides copies of ISO 13485, Medical Device Production License, Radiation Safety License, Export Sales Certificate, Trademark Registration and Medical Device Registration Certificates for tender submissions, procurement reviews and distributor onboarding.
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Related pages for CT X-ray tube selection, product specifications and global supply.
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