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Regulatory Compliance

Here you’ll find the quality management system certification information as well as product approvals for medical products.

  • QMS Certificate (pdf)
  • Product certificate database (web)

QUALITY MANAGEMENT

Europe

g.tec medical engineering GmbH is certified according to EN ISO 13485.

Japan/Canada/USA

  • MDSAP – Medical Device Single Audit Program (pdf)

CERTIFICATION AND APPROVALS

Europe

CE-Certification according to directive 93/42/EEC, Annex II:

  • EC Certificate for active and passive stimulation devices for neurological diagnosis and therapy devices for neuromuscular stimulation devices (pdf)
  • Product certificate database (web)
  • Declaration of Conformity for g.Estim PRO
  • Declaration of Conformity for cortiQ
  • Declaration of Conformity for recoveriX
  • Declaration of Conformity for g.Nautilus PRO
  • Declaration of Conformity for g.Nautilus Research
  • Declaration of Conformity for g.HIamp
  • Declaration of Conformity for g.Estim FES
  • Declaration of Conformity for g.SENSOR 8 fNIRS

USA

g.tec medical engineering GmbH is a FDA registered company:

  • Company Registration Information USA

FDA cleared products according to 510(k):

  • cortiQ | K191432
  • g.HIamp | K123255
  • g.Nautilus PRO | K171669
  • g.Estim PRO | K173684
  • g.Estim FES | K200088 
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