Regulatory Compliance

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

Quality Management System

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

Quality Management System Certificate (pdf)
Product Certificate Database

Certification / Approvals

Europe

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

EC Certificate (pdf)
Product Certificate Database

Declaration of Conformity

  • g.Estim PRO | DOC

USA

g.tec medical engineering GmbH is a FDA registered company: Company Registration Information USA

FDA cleared products according to 510(k):

  • g.USBamp | K060803
  • g.HIamp | K123255
  • g.NautilusPRO | K171669
  • g.Estim PRO coming soon
  • g.Estim FES coming soon