Allied Hill Enterprises, Ltd.
US Last updated 23 May 2026
- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
FDA establishments
- Allied Hill Enterprises, Ltd. Hong Kong · HK FEI 3010337881
What Allied Hill Enterprises, Ltd. makes
Allied Hill Enterprises, Ltd. manufactures liquid-filled ring teethers, including models 03807, 1962005, and 1962011, designed for oral sensory stimulation and teething relief in infants.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Frequently asked questions
What types of medical devices does Allied Hill Enterprises, Ltd. manufacture?
Allied Hill Enterprises, Ltd. specializes in liquid-filled ring teethers, such as models 03807, 1962005, and 1962011. These devices are specifically designed to provide oral sensory stimulation and teething relief for infants.
Where is Allied Hill Enterprises, Ltd. based?
Allied Hill Enterprises, Ltd. is based in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with local and federal medical device standards.
How are Allied Hill Enterprises, Ltd.’s devices classified under FDA regulations?
Allied Hill Enterprises, Ltd.’s liquid-filled ring teethers fall under Class II classification according to FDA regulations. This classification typically requires special controls in addition to general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Are Allied Hill Enterprises, Ltd.’s devices listed in any regulatory registries?
Yes, Allied Hill Enterprises, Ltd.’s devices are listed via FDA 510(k) clearance, which is a premarket submission required for Class II devices to demonstrate substantial equivalence to a legally marketed predicate device. This process ensures compliance with FDA requirements before commercial distribution.
Information
- Country
- US