# Hoya Global Distribution Center

FEI: 3017435679
Status: Active
Establishment types: Export Device to the United States But Perform No Other Operation on Device
Owner/operator: HOYA MEDICAL SINGAPORE PTE LTD (#10026402)

Address: 158/13 Moo 5, Tambol NongKham,, Amphur Siracha, Chonburi Chon Buri, 20110, TH

Mandatory US Agent: Hoya Surgical Optics

## Products

Total registered: 1
Top product codes: HQL
Regulation §: 886.3600

Proprietary names: iSert Preloaded IOL System (Model No. 251), iSert Preloaded IOL System (Model No. 250), iSert Preloaded IOL System (Model No. 230), IPure B3PC, IPure B1PY, IPure B1PC, PreVue C, IPure B3PY, iSert Preloaded IOL System (Model PY-60AD), iSert 255

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223017435679%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3017435679