EDENLUX Corp.
Country not established FDA
Part of Edenlux Corp.
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What EDENLUX Corp. makes
EDENLUX Corp. manufactures battery-powered vision training devices designed to improve visual fixation and binocular coordination. Their primary product, OTUS® Fixation, focuses on targeted vision exercises for users seeking to enhance visual alignment and stability.
The company’s portfolio is classified under Class I medical devices and is listed in the FDA’s Unique Device Identifier (UDI) database. The devices are regulated under US medical device laws, with compliance requirements aligned with FDA standards.
Catalogue
- GUDID
Company details
- DUNS number
- 696950408
FDA establishments
- Edenlux Corp. Seoul · KR FEI 3035494481
Frequently asked questions
How many devices does EDENLUX Corp. have in the registry?
The registry currently lists 1 device for EDENLUX Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list EDENLUX Corp.'s devices?
Among its 1 most recently registered device, EDENLUX Corp. has devices listed in FDA GUDID (1 device).
What risk classes do EDENLUX Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for EDENLUX Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from EDENLUX Corp. in the registry?
The most recently registered devices listed for EDENLUX Corp. include OTUS® Fixation, Vision Training, Binocular LRS2-400FB1-M0.
Which FDA establishments are linked to EDENLUX Corp.?
1 FDA establishment is linked to EDENLUX Corp. in the registry; they are listed on the company page.