HMD do Brasil - Industria, Importações e Exportações

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sac@hmdbio.com.br

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BIOMOLECULAR TECHNOLOGY | Licensiado pela HMD Brasil

HMD BioMedical Inc.

Bem-vindo!

HMD BioMedical Inc. – HMD was founded in 2000 by Dr. Tim Hsu, who has more than 32 years of experience in research and dedication in the area of blood glucose and whose specialization has been in Biosensor Electrochemistry and Biochemical Engineering in clinical laboratories.

HMD carries out commercial work in a large global area: Asia, Europe, the Middle East, Africa, North America and South America, with the supply of its products. HMD has manufactures in Taiwan, China, Germany, Canada and Brazil (works in advanced phase of construction).

HMD products have Certificate of Conformity with ISO 15197: 2013.

HMD Brasil will be the first company to manufacture the glusoce monitors and blood glucose test strips in Brazil.

15A21-Time Line of HMD QMS
15A21-Time Line of HMD

Year 2002

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

Year 2003

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

Year 2004

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

Year 2005

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

Year 2006

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

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 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 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 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 2011

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

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 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 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 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)

See the main certifications by accessing Here.