Licence and Certificates PDF Print E-mail
Written by BS   

HMD is the first company with MDSAP certified in Taiwan and to be the first manufacturer of the glucose monitors and blood glucose test strips in Brazil soon.

Licence and Certificates:

__ Year 2017

  • MDSAP Certified

 

__ Year 2015

  • FSC (TrueCheck) 004938
  • Central Drugs Standard Control Organisation – Indian (Licence to import drugs) NDC-328/11
  • ISO 9001:2008 & 13485:2003
  • Products are updated & claimed to meet EN ISO 15197:2013 (GlucoLeader Enhance & Enhance 2)

 

__ Year 2014

  • GMP
  • Central Drugs Standard Control Organisation – Indian (Licence to import drugs) NDC-119/11
  • EC- Certificate VTT-C-11201-02-1074–522-14
  • FDA (FIA G2) K131173
  • Central Drugs Standard Control Organisation – Indian (Licence to import drugs) NDC-183/14
  • Central Drugs Standard Control Organisation – Indian (Licence to import drugs) NDC-219/14

__ Year 2013

  • FSC (Cloudia) 003847
  • FDA (GoodLife CS-200) K121433
  • Agencia Nacional de Vigilancia Sanitaria-ANVISA (Meter Revalidation)
  • FSC (GoodLife) 004015
  • Agencia Nacional de Vigilancia Sanitaria-ANVISA (Strip Revalidation)
  • Registration Certificate for Medical Devise – China Certificate (Strip)
  • Australian Register of Therapeutic Goods Certificate

__ Year 2012

  • FSC (GlucoLeader NS100_109) 003592
  • FSC (GlucoLeader CS-100) GDH KPH 003595
  • FSC (SoEasy) 003596
  • FSC (GlucoLeader AC300-305) 003658
  • FSC (GoodLife CS-200_301_KPH) 003663
  • FSC (GlucoLeader Salut) 003664
  • ISO 9001:2008 & 13485:2003 (new address)
  • Registration Certificate for Medical Devise – China Certificate (Meter)
  • FDA (GoodLife AC300-305) k113307
  • FDA (PreciChek Claudia) k120064
  • FSC (GoodLife_POCT) 003683
  • FDA (PreciChek NS_101 POCT) k113314

__ Year 2011

  • GMP (new address)
  • FSC (CS-200_300_301_QM) 003402

__ Year 2010

  • EC- Certificate VTT-C-5461-02-1074-386-10-P0
  • ISO 9001:2008 & 13485:2003 (new address)
  • Business Registration Certificate for Pharmaceutical Manufacturer

__ Year 2009

  • FSC (Bonjour) 00271
  • Registration Certificate for Medical Devise – China Certificate (Meter)
  • EC- Certificate VTT-C-4412-02-1074-358-09-P0
  • ISO 9001:2008 & 13485:2003 (old address)

__ Year 2008

  • EC- Certificate VTT-C-0392-02-1074-248-P3 (New Products)
  • GMP (old address)
  • Registration Certificate for Medical Devise – China Certificate (Strip)
  • Agencia Nacional de Vigilancia Sanitaria-ANVISA (Products Registration)

__ Year 2007

  • FSC (Easy Test) 002345
  • FSC (GLM_71 to GLM_77) 002355
  • EC- Certificate VTT-C-0392-02-1074-248-P2 (New Products addction)

__ Year 2006

  • EC- Certificate VTT-C-0392-02-1074-248-P0
  • ISO 9001:2000 & 13485:2003 (old address)

__ Year 2005

  • GMP (old address)
  • FSC (GlucoLeader Value) 001945
  • FSC (GlucoLeader Enhance) 001946

__ Year 2004

  • Registration Certificate for Medical Devise – China Certificate
    (Meter) (old address)
  • Registration Certificate for Medical Devise – China Certificate (Strip) (old address)

__ Year 2003

  • FDA (GlucoseLeader Value) k023279 (Reg. No. 21 CRF 862.1345)
  • FDA (GlucoseLeader Enhance) k032985

 

__ Year 2002

  • EC- Certificate TUO-1074-136-PO
  • ISO 9001:1994 & 13485:1996 (old address)