Production Facilities

At TMR Enterprises, our state-of-the-art production facilities are designed to ensure the highest standards of quality and efficiency in manufacturing medical devices. Located in Ahmedabad, India, our facility is equipped with advanced technology and infrastructure to meet the diverse needs of the healthcare industry.

Key Features of Our Production Facilities:

1. Controlled Molding Area:

   • Our controlled molding area ensures precision and consistency in the production of medical devices, adhering to strict environmental controls.

2. Class 10,000 Clean Room:

   • We maintain a state-of-the-art Class 10,000 clean room, providing a highly controlled environment to prevent contamination and ensure the sterility of our products.

3. ETO Gas Sterilization Plant:

   • Our ETO gas sterilization plant is equipped with the latest technology to ensure the complete sterilization of medical devices, guaranteeing their safety and effectiveness.

4. Advanced Testing and Quality Control:

   • Our facilities include cutting-edge testing equipment and quality control processes to ensure that every product meets international standards and regulatory requirements.

5. Modern Manufacturing Amenities:

   • We utilize a range of modern amenities and equipment to support efficient production processes, from raw material handling to final product packaging.

Certifications and Compliance:

• ISO 9001:2008 and ISO 13485:2003:

  • Our production facilities operate in compliance with ISO 9001:2008 and ISO 13485:2003 standards, ensuring a robust quality management system.

• CE Marking:

  • All our products are CE marked, indicating conformity with European health, safety, and environmental protection standards.

• US FDA 510(k) Approval:

  • Several of our products have received US FDA 510(k) approval, reflecting our commitment to meeting stringent regulatory standards.

At TMR Enterprises, we continuously invest in our production facilities to enhance our capabilities and maintain our reputation for excellence in the manufacture of medical devices. Our commitment to quality, innovation, and customer satisfaction drives us to deliver the best products to healthcare providers worldwide.

TMR Enterprises Manufacturing Capabilities

TMR Enterprises’ manufacturing capabilities include:

• Tubing extrusion

• Injection molding

• Insert molding

• Blow molding

• Radio frequency (RF) sealing

• Ultrasonic welding

• Aseptic filling

• Assembly in clean rooms

• Form fill seal packaging