Castle Co.
Country not established
- Devices
- 21
What Castle Co. makes
Castle Co. manufactures medical device accessories and test systems for sterilization and environmental monitoring, including steam sterilizer integrators, aeration monitors, and conductive adhesive dispersers. Their portfolio also includes specialized washers for utensils and glassware, ethylene oxide (EO) exhaust hoods, and gas aeration units for medical equipment. The company produces test packs and packages designed to verify sterilization processes, such as the Tec-Test S.M.A.R.T. Pack and DayStar/Orbiter validation kits.
These devices are classified under FDA Class II, requiring premarket notification (510(k)) clearance. The products are listed in the FDA’s 510(k) registry, and the company operates from the United States.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Castle Co. have in the registry?
The registry currently lists 21 devices for Castle Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Castle Co.'s devices?
Among its 21 most recently registered devices, Castle Co. has devices listed in FDA 510(k) (21 devices).
What risk classes do Castle Co.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Castle Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Castle Co. in the registry?
The most recently registered devices listed for Castle Co. include STERILIZER, SERIES 3000, MODIFICATION TO, STERILIZERS, 3100 SERIES TRIM LINE, CASTLE TEC-TEST S.M.A.R.T. PACK and CASTLE TEC-TEST STEAM STERI. INTEGRATOR.