Company Profile
OMNIMATE -Professional MEDICAL products designer and manufacturer in various industries.
OMNIMATE ENTERPRISE CO., LTD. was established in 1998. It manufactures various kinds of medical devices and product, which are widely applied in Pre-Hospital, In-Hospital and Homecare covers of anesthesiology, gastroenterology, and respiratory areas. All the products are in line certified with FDA, ISO 13485, CE and TFDA. We have been exporting our products mainly to EU markets, Asia, America, and Middle-East.
The production area is 10,000 cleaning room follows strict codes: clothing changing, hand-washing, disinfection, and air-shower. The flow of material and movement of personnel inside the production area is strictly separated, with different inlets and outlets for materials, finished products, and production staffs. The total clean production area occupies 4,500m2.
We follow AQL1.0 S4 to inspect our products in order to give the better quality to our customer. We also consider exceptional quality and service as our primary objective day-by-day. It is our goal to serve the healthcare needs of our consumers throughout the World; fundamentally aiming to develop innovative medical products that will save or improve the quality of life.
Our sterilization factory area occupies 2,000-meter square. We have 4 EO sterile machines, each one is 13m2 which follow CE standard. Each machine can sterile 5 pallets for the size of 100x120cm.
Milestone
| Year | Issued |
|---|---|
| 1998 | Establish headquarter in New Taipei city |
| 2000 | Has 1st Trading company in Shanghai |
| 2003 | Certificate acquisition: ISO13485, CE |
| 2004 | FDA Listing for medical products |
| 2006 | 1st factory in Kunshan(China) |
| 2012 | Extended facility for increasing capacity |
| 2014 | 2nd factory in Yilan (Taiwan) |
| 2015 | Certificate acquisition: ISO13485, CE, TFDA, FDA |
| 2016 | GMP certificate for Yilan factory |
| 2017 | 1st Sterilization factory in Yilan |
| 2018 | GMP certificate for sterilization factory |
