Certifications and Awards
Year | Text | |
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2022 |
Achieves the Taiwan Medical Device Quality Management System (QMS) certification. |
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2021 |
Achieves the International Organization for Standardization (ISO) ISO 13485:2016 & EN ISO 13485:2016 certification renewed. |
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2020 |
"MicroBase" Ventilator tubing (Non-Sterile) achieves TFDA Class I medical device approval. |
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Achieves Halal (حلال)Certificate |
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2019 |
Pocket Air ® SILENTNEB achieves China FDA approval. |
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Pocket Air® Inline Nebulizer achieves China FDA approval. |
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2018 |
Pocket Air® Portable Nebulizer achieves FDA 510(k) approval. |
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2017 |
Achieves the International Organization for Standardization (ISO) 13485:2016 certification. |
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Achieves the International Organization for Standardization (ISO) 22716: 2007 certification. |
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2016 |
Achieves the International Organization for Standardization (ISO) 9001:2015 certification. |
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Achieves Taiwan GMP certification. |
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Pocket Air® Portable Nebulizer awarded 2016 Taiwan Excellence Award. ![]() |
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Pocket Air® Portable Mesh Nebulizer achieves Canada Medical Device Regulation approval. |
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Pocket Air® Portable Mesh Nebulizer achieves China FDA approval. ![]() |
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2015 |
Pocket Air® Tube awarded Product of Outstanding Interest in 2015 ERS International Congress. |
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Pocket Air® Portable Nebulizer awarded the 22th Taiwan SMEs Innovation Award |
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Achieves Taiwan Medical device Selling License. |
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2014 |
Pocket Air® Portable Nebulizer awarded the 2014 Taipei Int'l Invention Show and Technomart Gold Award. |
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ISO 22716:2007 |
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MicroBase Manual surgical instrument for general use (Non-Sterile) achieves TFDA Class II medical device approval. |
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Pocket Air® Portable Nebulizer achieves TFDA Class II medical device approval. |
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Pocket Air® Portable Nebulizer achieves CE 0120 marking. ![]() |
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Pocket Air® Portable Nebulizer awarded 2014 Medtrade HomeCare New Product Pavilion Winner Providers Choice GOLD Award. |
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2013 |
Achieves Taiwan Medical device Manufacturing License. |
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Achieves the International Organization for Standardization (ISO) 9001: 2008 certification. |
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Achieves the International Organization for Standardization (ISO) 13485:2012 certification. |
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2012 |
MicroBase awarded the 2012 Taipei Biotech Awards Biotechnology Commercialization Award Silver Medal Award. |
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2010 |
MicroBase awarded the 18th Taiwan Industrial Technology Advancement Award. |
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Portable Micro Sprayer awarded the 17nd Taiwan SMEs Innovation Award. |
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2009 |
Achieves the International Organization for Standardization (ISO) 9001:2008 certification. |
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2008 |
Pd-Ni vibrating mesh (aperture plate) achieves FDA approval. |
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2003 |
Achieves the International Organization for Standardization (ISO) 9001:2000 certification. |