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