Technitex, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Technitex, Inc. makes
Technitex, Inc. manufactures diagnostic ophthalmic devices, including the QRK 100 Qualitative Ring Keratoscope and the VKG 2000 and VKG 1000 Video Keratometers. These instruments are designed for corneal topography and refractive error assessment in clinical settings.
The company’s devices are classified under FDA Class I and are subject to 510(k) clearance in the United States. The portfolio is listed in the FDA’s 510(k) registry, reflecting their regulatory status. Technitex, Inc. is based in the United States.
Catalogue
Qrk 100, Qualitative Ring Keratoscope Ref K882902
Regimes: 510(k) Registry: 510(k)Vkg 2000 Video Keratometer Ref K893968
Regimes: 510(k) Registry: 510(k)Vkg 1000, Video Keratometer Ref K883471
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Technitex, Inc. have in the registry?
The registry currently lists 3 devices for Technitex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Technitex, Inc.'s devices?
Among its 3 most recently registered devices, Technitex, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Technitex, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Technitex, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Technitex, Inc. in the registry?
The most recently registered devices listed for Technitex, Inc. include QRK 100, QUALITATIVE RING KERATOSCOPE, VKG 2000 VIDEO KERATOMETER and VKG 1000, VIDEO KERATOMETER.