Sterilucent, Inc.
United StatesFDA applicant, unverified
- Devices
- 11
What Sterilucent, Inc. makes
Sterilucent, Inc. manufactures sterilization systems and accessories for healthcare settings, including hydrogen peroxide sterilizers, biological indicators, and process challenge devices. Their portfolio includes self-contained sterilization containers, chemical indicators, and specialized devices designed to validate sterilization cycles for medical instruments and equipment.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are intended for use in sterilization processes and are listed in the FDA’s 510(k) database. Sterilucent, Inc. is based in the United States.
Catalogue
Search and filter all 11 devicesCompany details
- DUNS number
- 005634969
- [email protected]
- Phone
- 1-877-721-8405
Frequently asked questions
How many devices does Sterilucent, Inc. have in the registry?
The registry currently lists 11 devices for Sterilucent, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sterilucent, Inc.'s devices?
Among its 11 most recently registered devices, Sterilucent, Inc. has devices listed in FDA 510(k) (7 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sterilucent, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Sterilucent, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sterilucent, Inc. in the registry?
The most recently registered devices listed for Sterilucent, Inc. include Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V HC 80TT-120-001, Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle SL291, Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle SL290 and Sterilucent™ Sterilant Disc SL001.