Certifications of Technomed Medical Parts & Equipment TEMPE
Quality, compliance, and customer trust form the cornerstone of our enterprise at TEMPE. Our wide array of certifications and accreditations is proof of our adherence to international benchmarks set for medical equipment and making sure quality is guaranteed right from procurement to after-sales service.
FDA Establishment Registration U.S. Food and Drug Administration
We are registered with the U.S. Food and Drug Administration (FDA) under CAN Technomed Trading Ltd., with Registration Number 3015276088 and FEI Number 3015276088. Our active registration is valid until 2025 and ensures compliance with FDA guidelines for medical equipment distribution. This recognition highlights our role as a trusted provider of medical imaging equipment.
ISO 13485:2016 represents the quality management system accreditation concerning medical devices. In essence, the present system indicates that our company has implemented international standards in trade, training, refurbishment, installation, and after-sales services regarding medical equipment and its parts. This certification also reassured that our technical competence in imaging systems, enabled us to reach distribution and maintenance.
Certification Date: Certificate issued by Institute of Global Certification, IGC, is valid up to 21st August 2027.
Medical Device Establishment License (MDEL)
We are proud to hold a Medical Device Establishment License MDEL issued by Health Canada. The license legally empowers us to implement the major roles outlined in the Food and Drugs Act of Canada, which include:
Scope of Activities:
- Distribution Records
- Complaint Handling
- Recalls
- Mandatory Problem Reporting
- Handling, Storage, and Delivery
- Installation
- Corrective Actions
- Servicing
This license number 10479 and Company ID 149244 assures us that we will be bound by the strict regulatory requirements of Health Canada.
ISO 13485:2016 Certification
ISO 13485:2016 represents the quality management system accreditation concerning medical devices. In essence, the present system indicates that our company has implemented international standards in trade, training, refurbishment, installation, and after-sales services regarding medical equipment and its parts. This certification also reassured that our technical competence in imaging systems, enabled us to reach distribution and maintenance.
Certification Date: Certificate issued by Institute of Global Certification, IGC, is valid up to 21st August 2027.
IAMERS Membership
Equally important, Technomed Medical Parts & Equipment is proud to be a member of the IAMERS -The International Association of Medical Equipment Remarketers and Servicers, which denotes our commitment to high ethical standards and professionalism in the buying and reselling of used medical equipment and the servicing of the same. This is proof of our integrity and pledge toward transparency in every aspect of the business processes.
GMP Certification (Good Manufacturing Practices)
We have been accredited by the Ministry of Food and Drug Safety of Korea to GMP for diagnostic imaging system products. This certification by the Korea Testing & Research Institute justifies our conformance to predefined manufacturing and quality control standards for medical devices.
- Manufacturer: CAN Technomed Trading Ltd.
- Certificate Number: KTR-BBBA-17288
- Scope: Diagnostic Imaging Systems
- Issued By: Korea Testing & Research Institute (KTR)
- Certificate Validity: May 10, 2023 – May 9, 2026.
Accreditations listed at Technomed Medical Parts & Equipment are evidence of worldwide concern for quality, safety, and customer care. Each one of them is one more seal of trust and a guarantee to our customers, who can confidently rely on us for all their needs in medical imaging. Please do not hesitate to contact us for details or to authenticate any of the above certifications.