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Sign in to claim this brandWhat BIOPROTECT LTD makes
Bioprotect Ltd manufactures the BioProtect Balloon Implant™ System, a radiotherapy protection spacer designed to reduce radiation exposure to healthy tissue during cancer treatment. This device is intended for use in prostate radiotherapy to create space between the prostate and surrounding organs, thereby minimizing collateral damage.
The company’s product portfolio is classified under FDA’s Class II medical devices and is listed in the FDA’s Unique Device Identifier (UDI) database. Bioprotect Ltd operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bioprotect Ltd manufacture?
Bioprotect Ltd specializes in radiotherapy protection spacers, specifically the BioProtect Balloon Implant™ System. This device is designed to create space between the prostate and adjacent healthy tissue during prostate radiotherapy, helping to reduce unintended radiation exposure to surrounding organs.
Where is Bioprotect Ltd based, and what regulatory listings apply to its devices?
Bioprotect Ltd is based in the United States. Its devices, including the BioProtect Balloon Implant™ System, are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify medical devices for regulatory and safety purposes.
How are Bioprotect Ltd’s devices classified by regulatory authorities?
Bioprotect Ltd’s devices fall under the FDA’s Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as the BioProtect Balloon Implant™ System.
What is the primary purpose of the BioProtect Balloon Implant™ System?
The BioProtect Balloon Implant™ System is intended to act as a radiotherapy protection spacer during prostate cancer treatment. By physically separating the prostate from nearby healthy tissue, it aims to minimize radiation exposure to organs like the rectum, thereby reducing potential side effects from collateral damage.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 649754660
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BioProtect Balloon Implant™ System | 5135 | FDA UDI | Class II | Active |
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