2026, SCIAN|HONSUN has achieved two major international regulatory milestones for its portable oxygen concentrator. This accomplishment goes beyond a single product breakthrough — it demonstrates our overall competence in respiratory health, validated by the world's most stringent regulatory frameworks.
In June 2026, the portable oxygen concentrator (models: Ares-6A, Ares-4A) received FDA 510(k) clearance (K252399). Utilizing molecular sieve / pressure swing adsorption (PSA) technology with breath detection, the device delivers pulsed, high-concentration oxygen (90%~96%) for patients requiring supplemental oxygen in home, institutional, and transport settings.
As early as 2025, SCIAN|HONSUN successfully passed TÜV SÜD audits and was granted a Quality Management System Certificate under the EU Medical Device Regulation (EU) 2017/745 (Certificate No. G15 074340 0024 Rev.00). The certification covers comprehensive QMS assessment, including sterilization, metrological traceability, and reusable device management (where applicable), ensuring sustained EU market access.
Looking ahead, SCIAN|HONSUN remains committed to delivering safe and reliable respiratory health solutions to patients worldwide, upholding the highest global standards.
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