Gentex Corporation
United StatesFDA applicant, unverified FDA FEI 1000261180
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Gentex Corporation makes
Gentex Corporation manufactures medical devices including THE LENS OR OMMI-GARD, a patient isolation unit (Model G019-1000), and the RX LENS Series.
The company's products are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Gentex Corporation is based in the US.
Catalogue
The Lens Or Ommi-Gard Ref K800521
Regimes: 510(k) Registry: 510(k)Patient Isolation Unit, Model G019-1000 Ref K080117
Regimes: 510(k) Registry: 510(k)Rx Lens Series Ref K772024
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000261180
- Address
- 600 North Centennial Street, Zeeland, MI, 49464
Frequently asked questions
How many devices does Gentex Corporation have in the registry?
The registry currently lists 3 devices for Gentex Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gentex Corporation's devices?
Among its 3 most recently registered devices, Gentex Corporation has devices listed in FDA 510(k) (3 devices).
What risk classes do Gentex Corporation's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gentex Corporation's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gentex Corporation in the registry?
The most recently registered devices listed for Gentex Corporation include THE LENS OR OMMI-GARD, PATIENT ISOLATION UNIT, MODEL G019-1000 and RX LENS SERIES.