FDA 510(k) Medical Device Manufacturers - Indonesia

Leading Indonesia FDA 510(k) manufacturers include Arista Latindo Industrial Ltd. P.T, Pt. Medisafe Technologies, P.T. Irama Dinamika Latex and 14 others.

Indonesian medical device manufacturers have submitted 71 FDA 510(k) notifications since 1989, with a 100% clearance rate across 17 manufacturers. Indonesia's FDA submissions reflect the country's established manufacturing capacity in medical gloves, disposable devices and examination equipment serving global healthcare supply chains.

Active in FDA 510(k) submissions since 1989. Many Indonesia manufacturers work with FDA regulatory consultants to support U.S. market entry.