Certifications

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  Approved by U.S. Food and Drug Administration Safety Agency (FDA)

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  Approved by UK Conformity Assessed (UKCA)

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  Approved by the MEDIcept in United Arab Emirates

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  Approved by the Food and Drug Administration (FDA) in Thailand

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  Approved by the Food and Drug Administration (FDA) in Taiwan

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  Ministry of Food and Drug Safety in Korea

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  Approved by Pharmaceutical and Medical Devices Agency (PMDA) in Japan

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  Approved by the Central Drug Standard Control Organization (CDSCO) in India

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  Acquired European Community Certification CE 0197

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  Approved by the National Medical Products Administration (NMPA) in China

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  Approved by the Health Canada

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  INMETRO quality system certification in Brazil

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  Approved by ANVISA in Brazil

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  Approved by the Therapeutic Goods Administration (TGA) in Australia

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  MDSAP
  Quality system certification

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  ISO 13485
  Quality system certification

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  ISO 9001
  Quality system certification

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  GMP Certification
  Standards for medical device manufacturing and quality control

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  FDA Approved

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  CE Certified

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  ISO 13485 Certification

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  TUV Certification

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  GMP Certification