Derata Corp.
United StatesFDA applicant, unverified
- Devices
- 6
What Derata Corp. makes
Derata Corp. manufactures a series of single-use, pre-filled injection devices designed for subcutaneous and intramuscular drug delivery, including variants for insulin and other biologics. The portfolio includes models with fixed-dose and adjustable-dose capabilities, as well as versions optimized for specific patient populations or use cases. Devices feature disposable needles and integrated safety mechanisms to reduce user exposure risk. Some models incorporate electronic connectivity for dose tracking and data logging.
All listed devices fall under Class II regulatory classification in the US and are authorised via 510(k) premarket notifications through the FDA. The portfolio is registered under the FDA’s 510(k) database, reflecting compliance with US medical device regulations. The company operates from the United States.
Catalogue
Medi-Jector Ref K772129
Regimes: 510(k) Registry: 510(k)Derata Medi-Jector Iv Ref K864561
Regimes: 510(k) Registry: 510(k)Derata Medi-Jector Iii Ref K844111
Regimes: 510(k) Registry: 510(k)Derata Medi-Jector Pro Ref K844244
Regimes: 510(k) Registry: 510(k)Medi-Jector Ii Ref K834044
Regimes: 510(k) Registry: 510(k)Derata Medi-Jector V Ref K883847
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Derata Corp. have in the registry?
The registry currently lists 6 devices for Derata Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Derata Corp.'s devices?
Among its 6 most recently registered devices, Derata Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Derata Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Derata Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Derata Corp. in the registry?
The most recently registered devices listed for Derata Corp. include MEDI-JECTOR, DERATA MEDI-JECTOR IV, DERATA MEDI-JECTOR III and DERATA MEDI-JECTOR PRO.