# China medical device registration

Pumen Tech Wins Approval for DHEA‑S ECL Test as Chinese IVD Firms Broaden Diagnostic Menus

Pumen Technology has received domestic regulatory approval in Guangdong for an electrochemiluminescence DHEA‑S assay, expanding its in‑vitro diagnostic reagent menu. The clearance strengthens the company’s product offering but does not guarantee sales, which will depend on clinical validation, procurement and reimbursement dynamics.