Omnimate Enterprise Co., Ltd. - OMNIMATE - A professional Contracting manufacturing and Assembling of Plastic and silicone products.

Omnimate Medical Device Production | FDA Certified Manufacturing

Omnimate's ISO 13485 certified production facility features injection molding, clean room assembly, and EO sterilization for medical devices worldwide.

Advanced Medical Device Manufacturing Facility

Omnimate's state-of-the-art production capabilities include ISO 13485 certified injection molding, clean room assembly, and comprehensive sterilization services for global healthcare applications.

Production

Production

Allow me to introduce our factory to you:

First I will take you to visit our "Injection Room"

Our Injection area is 300,000 cleaning room follows strict codes: clothing changing, hand-washing, disinfection, and air-shower. We will highly strict requirements for our operators before they enter.

Now, we had already had 4 plastic Injection Machines, 2 Silicone Injection Machines, 1 Blow Molding Machine, and 1 Extrusion machine. In the future, we will add more different types of machines to reach every customer request.

Second, I would like to show you our "Clean Room"

Our Cleanroom area is 10,000 cleaning room follows strict codes: clothing changing, hand-washing, disinfection, and air-shower.  We will highly strict requirements for our operators before they enter.

We will assemble all the product which need to be sterilized. For example like Laryngeal Mask Airway, Nasopharyngeal Airway...etc.

Next, It's our "Assembly Room"

We will assemble all the products no matter is medical or any other kinds of product in this area which is not including the products need to be sterilized. The maximize production capacity are FIVE lines at the same time.

Last but not least, I would like to show you the "Meeting Room"

Our Meeting Room is Simple and Elegant. We also put a few showcases in order that anyone can easily understand what kind of products we produce.

Hope you know more about Omnimate!!!!!!!

How can we ensure our anesthesia equipment meets strict sterility standards and regulatory requirements for patient safety?

Omnimate's 10,000 sq ft ISO 13485 certified clean room is specifically designed for assembly of sterilizable products like Laryngeal Mask Airways and Nasopharyngeal Airways. Our facility maintains AQL 1.0 S4 compliance with comprehensive quality control through IQC, IPQC, and FQC standards, backed by integrated EO sterilization services. With 28 years of FDA, ISO 13485, and CE MDD certifications, we guarantee your anesthesia equipment meets the highest international safety and sterility standards. Contact our procurement team to learn how we can support your hospital's equipment specifications and regulatory compliance needs.

As an FDA, ISO 13485, and CE MDD certified manufacturer with 28 years of industry experience, Omnimate delivers end-to-end solutions from prototype development to full-scale series production, including integrated EO sterilization services. Our experienced R&D team combines flexible customization capabilities with rapid response to customer requirements, positioning us as a trusted global partner for hospitals, emergency services, anesthesiology departments, critical care facilities, and gynecology centers. Contact us today to discuss how our manufacturing excellence and regulatory expertise can support your medical device supply chain.