Company Profile / Omnimate Enterprise Co., Ltd. has been manufacturing high quality medical, industrial and commercial components and finished products since 1998. Also an ISO 9001, ISO 13485, CE MDD, FDA and GMP certified registered manufacturer in Taiwan.

Respiratory | Silicone Ambu Bag | Surgical Mask manufacturer - Omnimate. Made in Taiwan FDA, ISO 13485, CE and TFDA medical device & EO sterilizatoin service supplier - Omnimate. Medical devices sold to EU markets, Asia, America and Middle-East. Medical product, including resuscitator, laryngoscope, laryngeal mask airway, surgical mask, anesthesia face mask, endotracheal tube, CPR mask, PAD mask, oxygen mask, aspiratory, speculum, etc. Pre-hospital, In-hospital and homecare medical device and product manufacturing and supply.

omni.mate@msa.hinet.net

On Duty: 8:30~17:30

About Omnimate

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
YearIssued
1998Establish headquarter in New Taipei city
2000Has 1st Trading company in Shanghai
2003Certificate acquisition: ISO13485, CE
2004FDA Listing for medical products
20061st factory in Kunshan(China)
2012Extended facility for increasing capacity
20142nd factory in Yilan (Taiwan)
2015Certificate acquisition: ISO13485, CE, TFDA, FDA
2016GMP certificate for Yilan factory
20171st Sterilization factory in Yilan
2018GMP certificate for sterilization factory

company proflie

Why Omnimate

It won't be wrong to take our services as your business tool!

Satisfy quality

Satisfy quality

Follow IQC,IPQC, FQC, ISO 13485 regulation and AQL 1.0 S4

High effectiveness and elasticity

High effectiveness and elasticity

Flexible attitude, Quick response, Catch up the customer requirement.

Experienced team& Well Service

Experienced team& Well Service

Well-Experience RD team to develop the new products. Offer well service to customer.