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!

A HMD BioMedical Inc. – HMD foi fundada em 2000 pelo Dr. Tim Hsu, o qual possui mais de 32 anos de experiência em pesquisa e dedicação na área de glicose sanguínea e cuja especialização tem sido em Biossensor Eletroquímica e Engenharia Bioquímica em laboratórios clínicos.

A HMD realiza um trabalho comercial em uma grande área global a saber: Ásia, Europa, Oriente Médio, África, América do Norte e América do Sul, com o fornecimento de seus produtos. A HMD possui fabrica em Taiwan, China, Alemanha, Canadá e no Brasil (obras em fase avançada de construção).

Os produtos da HMD possuem Certificado de Conformidade ISO 15197:2013.

A HMD Brasil será a primeira empresa a fabricar glicosímetros e tiras de teste de glicemia no Brasil.

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)
  • Certificate ISO 15197:2013