FDA Device Establishments · JSON-LD · Markdown

PT Giken Precision Indonesia

FEI 3009865005 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active

FEI Number3009865005
Owner / OperatorGiken Sakata (S) Ltd (#10087342)
AddressJL. Yos Sudarso Citra Buana Industrial Park II Lot 2 Batu Ampar Batam, Batam Riau, 29432, ID
Mandatory US AgentReactDx
Registration expiry2026
Initial importer flagN
Registered products2
Product codes (top 20)MLO, DRG
Regulation § (21 CFR)870.2800, 870.2910
Proprietary namesTelePatch Cardiac Monitor

External sources

Source: openFDA. Public-domain (CC0).