All Quality Standards in Place

AirSep Corporation is the ONLY PSA oxygen manufacturer that meets the following standards of construction

Our Certifications

  • US FDA
  • CE Medical Devices for design, manufacturing as per Directive 93/42/EEC under class IIb
  • NFEN ISO 13485:2016
  • ASME VIII ( American Society of Mechanical Engineers)
  • Indian FDA
  • NRTL-UL 3101.1 ( Nationally Recognized Testing Laboratory/Underwriters Lab)
  • NEMA ( National Electrical Manufacturers Association)
  • CSA/CRN ( Canadian Standards Association/Canadian Registration Number)

The system complies with

  • USP93XXII (United States Pharmacopoeia)
  • EUROPIAN Pharmacopoeia
  • Indian Pharmacopoeia
  • HTM 2022
  • HTM 02-01
  • ISO 7396-1 & EN 737-3
  • ISO/DIS 10083 (International Organization for Standardization)