Manufacturer Intelligence · Based on 75,370 FDA 510(k) records · 74 countries

FDA 510(k) Medical Device Manufacturers - Indonesia

Indonesian medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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6
Manufacturers
Indonesia
Country

Indonesia FDA 510(k) Overview

5
Manufacturers
9
Submissions
100%
Clearance rate

Leading Indonesia FDA 510(k) manufacturers include Pt. Medisafe Technologies, Pt. Universal Gloves, Pt. Maja Agung Latexindo and 3 others.

Indonesian medical device manufacturers have submitted 9 FDA 510(k) notifications since 2018, with a 100% clearance rate across 5 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 2018. Many Indonesia manufacturers work with FDA regulatory consultants to support U.S. market entry.

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.