Certificates & Patents

Certificering & patent Airmax

Certificates

Airmax® BV has obtained certificates that guarantee the quality and safety of our products. Those certificates are available on request to all companies, organisations, partners who have a business interest in our company. Those certificates are:

  • FDA
  • ISO 13485:2003 en ISO 13485:2003/AC:2009
  • CE
  • TGA eBS: 208297

FDA

Airmax ® BV has registered its medical device with the U.S. Food and Drug Administration (FDA) under 21, 807 et seq. of the United States code of Federal Regulations:

Establishment Registration: 3009227226
Device Classification Name: Dilator, Nasal
Product Code LWF
Regulation Number: 874.3900
Official Correspondent: Registar Corp
Ans U.S. Agent: 144 research Drive, Hampton, Virginia, 23666, USA
Telephone: +1-757-224-0177, Fax: +1-757-224-0179

ISO 13485:2003 en ISO 13485:2003/AC:2009

Airmax® BV is tested and certified for ISO 13485:2003 and ISO 13485:2003/AC:2009 for the following activities:

  • Production of medical devices that dilate the nasal cavity
  • Packaging of medical devices that dilate the nasal cavity
  • Sales of medical devices that dilate the nasal cavity

The Airmax® BV. ISO certificate has certificate number BE12/223574671.

To ensure quality and to maintain the certificate Airmax ® BV let themselves be checked every year by a certified company, at the moment this is done by SGS

CE

Airmax® BV has its product registered under the medical device directive 93/42/EEC:

Medical Device: Airmax
Risk class: Class I
Rule: Rule 5
Registration date: 18-06-2010

Number of Certificate of MDD-Annex VII assessment: 2010-MDD/CE084

Patents

Additionally, Airmax® BV has the following patents:

  • US PATENT D540,462
  • EU PATENT/ modelregistratie: 84140-01
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