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 FILLIGENT HISTORY OF ACHIEVEMENTS

 

 

COMPANY DEVELOPMENT
2001 

  • Founding of Filligent Limited by Melissa Mowbray-d’Arbela and Neal Stewart.

2005 

  • Filligent opens manufacturing facility in USA

2006

  • Goldman Sachs investment

2008

  • Filligent opens state-of-the-art R&D lab in Hong Kong

2009

  • Filligent opens manufacturing facility in China

 

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AWARDS

2009

 

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REGULATORY ACHIEVEMENTS
2009

  • European Union: First-ever CE-certification of anti-microbial surgical face mask as medical device
  • Australia: First-ever certification of anti-microbial surgical face mask as medical device

2010

  • Australia: First-ever post-market clearance from Australian Therapeutic Goods Administration for an anti-microbial surgical face mask
  • Hong Kong: First ever confirmation for an anti-microbial surgical face mask as medical device
  • European Union: First-ever post-market review and clearance from UK MHRA
  • European Union: First-ever anti-microbial medical-grade respirator approval under new FFP2:2009 standard

2011

  • Singapore: First-ever anti-microbial surgical face mask approval as a medical device
  • USA: First-ever anti-viral surgical face mask approval under new “OUK” medical device classification for anti-microbial/anti-viral surgical face masks

 

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FDA KEY DATES

2010

  • April 20, 2010: Filligent’s 510(k) first submission to the FDA

2011

  • May 23, 2011: Filligent’s final submission to FDA
  • May 28, 2011: Filligent achieves FDA approval for Series A BioMask surgical facemasks

 

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ISO/QUALITY
2010

  • Filligent and our manufacturing facilities achieve the ISO9001:2008 & ISO13485:2003 certificates for the design and development, production and quality control distribution of surgical face mask and anti-microbial personal protective device

 

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PRODUCT DEVELOPMENT
2007

  • Invention of MicroBlue Gen3 Technology

2008 

  • Invention of MicroBlue Gen4 Technology
  • Invention of the BioFriend™ Anti-microbial Textile
  • Application of Blue Shield Technology to the SMARTline [SMARTWipe™, SMARTdot™, SMARTpuff™, SMARTsole™

2009 

  • Introduction of Series R BioFriend™ BioMask™

2010 

  • Invention of Series A BioFriend™ Technology
  • Introduction of Series A BioFriend™ BioMask™ 
  • Introduction of SMARTline series of advanced personal hygiene protection 
    [SMARTWipe™, SMARTdot™, SMARTpuff™, SMARTsole™
  • Introduction of Series C Anti-viral BioFriend™ BioMask (anti-viral)
  • Introduction of the Improved Series A BioFriend™ BioMask™ 

2011

  • Invention of Series D BioFriend™ BioMask™ (anti-microbial) and Series E BioFriend™ BioMask™ (anti-spores including anthraz and c.diff)

 

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DISTRIBUTION

2009

  • July 2009 Distribution agreement for US government sales
  • September 2009 Distribution agreement for EU occupational sales
  • October 2009 Distribution agreement for sales in Malaysia

2010

  • March 2010 Distribution agreement for sales to Australia dental channels
  • March 2010 Distribution agreement for sales in Taiwan
  • March 2010 Distribution agreement for sales in Singapore
  • June 2010 Distribution agreement for sales in Thailand
  • August 2010 Distribution agreement for sales to US and EU healthcare and other markets

 

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