Certifications & compliance documentation.
Every BriterAir Medical device shipped by RxMed Supply is accompanied by the documentation required to satisfy the medical device regulators in its destination market. Copies of any of the documents below are available on request during your wholesale quote process.
CE Certificate & EU Declaration of Conformity
European conformity certification for regulated medical devices.
FDA Listing / 510(k)
US Food & Drug Administration authorization and Establishment Listing where applicable.
ISO 13485
Quality Management System certification covering design, manufacture and distribution.
IEC 60601
General requirements for basic safety and essential performance of medical electrical equipment.
ISO 80601-2-69
Particular requirements for the basic safety and essential performance of oxygen concentrators.
Oxygen Purity Testing Report
Independent verification of 90–96% oxygen concentration performance.
Alarm Testing Report
Audible and visual alarm system verification report.
Battery UN 38.3 Documentation
Lithium battery transportation safety documentation.
Warranty & Spare Parts Commitment
Written commitment covering the product lifecycle.