Albert Browne , Ltd.
US Last updated 23 May 2026
- Devices
- 61
- Registries
- GUDIDEUDAMEDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
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FDA establishments
- Albert Browne Ltd. LEICESTER · GB FEI 3001168737
What Albert Browne , Ltd. makes
Albert Browne, Ltd. manufactures chemical and physical sterilization process indicators, including reusable test strips for validating medical device disinfection solutions. Their product line also includes reusable sterilization indicators for monitoring sterilization cycles, such as those used in autoclaves and other sterilization equipment.
The company’s devices are regulated under FDA Class I and Class II classifications, with submissions recorded in the FDA 510(k) and UDI registries. The portfolio is listed in the United States.
Frequently asked questions
What types of medical devices does Albert Browne, Ltd. manufacture?
Albert Browne, Ltd. specializes in devices that validate sterilization and disinfection processes. Their products include chemical and physical sterilization process indicators—such as reusable test strips—and reusable sterilization indicators for monitoring cycles in equipment like autoclaves. These devices ensure that sterilization and disinfection procedures meet required standards.
Where is Albert Browne, Ltd. based, and where are their devices regulated?
Albert Browne, Ltd. is based in the United States. Their devices are regulated under U.S. FDA guidelines, with submissions appearing in the FDA 510(k) and UDI registries. This means their products are tracked for compliance with U.S. medical device regulations, including classification under FDA Class I or Class II.
Which regulatory registries list Albert Browne, Ltd.’s devices?
Albert Browne, Ltd.’s devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track submissions for devices classified under FDA regulations, ensuring transparency in their regulatory status.
How are Albert Browne, Ltd.’s devices classified under FDA regulations?
Albert Browne, Ltd.’s devices fall under FDA Class I or Class II classifications. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose and potential risk, as outlined in FDA guidelines.
Information
- Country
- US