Certifications and Awards

Certifications and Awards
Year Text
2022

Achieves the Taiwan Medical Device Quality Management System (QMS) certification.

 
2021

Achieves the International Organization for Standardization (ISO) ISO 13485:2016 & EN ISO 13485:2016 certification renewed.

 
2020

"MicroBase" Ventilator tubing (Non-Sterile) achieves TFDA Class I medical device approval.

 
 

Achieves Halal (حلال)Certificate

 
2019

Pocket Air ® SILENTNEB achieves China FDA approval.

 
 

Pocket Air® Inline Nebulizer achieves China FDA approval.

 
2018

Pocket Air® Portable Nebulizer achieves FDA 510(k) approval.

 
2017

Achieves the International Organization for Standardization (ISO) 13485:2016 certification.

 
 

Achieves the International Organization for Standardization (ISO) 22716: 2007 certification.

 
2016

Achieves the International Organization for Standardization (ISO) 9001:2015 certification.

 
 

Achieves Taiwan GMP certification.

 
 

Pocket Air® Portable Nebulizer awarded 2016 Taiwan Excellence Award.

台灣精品獎
 
 

Pocket Air® Portable Mesh Nebulizer achieves Canada Medical Device Regulation approval.

 
 

Pocket Air® Portable Mesh Nebulizer achieves China FDA approval.

CFDA
 
2015

Pocket Air® Tube awarded Product of Outstanding Interest in 2015 ERS International Congress.

 
 

Pocket Air® Portable Nebulizer awarded the 22th Taiwan SMEs Innovation Award

 
 

Achieves Taiwan Medical device Selling License.

 
2014

Pocket Air® Portable Nebulizer awarded the 2014 Taipei Int'l Invention Show and Technomart Gold Award.

 
 

ISO 22716:2007

 
 

MicroBase Manual surgical instrument for general use (Non-Sterile) achieves TFDA Class II medical device approval.

 
 

Pocket Air® Portable Nebulizer achieves TFDA Class II medical device approval.

 
 

Pocket Air® Portable Nebulizer achieves CE 0120 marking.

CE0120
 
 

Pocket Air® Portable Nebulizer awarded 2014 Medtrade HomeCare New Product Pavilion Winner Providers Choice GOLD Award.

 
2013

Achieves Taiwan Medical device Manufacturing License.

 
 

Achieves the International Organization for Standardization (ISO) 9001: 2008 certification.

 
 

Achieves the International Organization for Standardization (ISO) 13485:2012 certification.

 
2012

MicroBase awarded the 2012 Taipei Biotech Awards Biotechnology Commercialization Award Silver Medal Award.

 
2010

MicroBase awarded the 18th Taiwan Industrial Technology Advancement Award.

 
 

Portable Micro Sprayer awarded the 17nd Taiwan SMEs Innovation Award.

 
2009

Achieves the International Organization for Standardization (ISO) 9001:2008 certification.

 
2008

Pd-Ni vibrating mesh (aperture plate) achieves FDA approval.

 
2003

Achieves the International Organization for Standardization (ISO) 9001:2000 certification.