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Sign in to claim this brandBioProtect
Israel·IL-MF-000013165
Last updated September 18, 2026
About
The information contained herein is provided for information purposes only and is not intended to replace discussions with a healthcare provider. The products discussed herein may have different product labelling in different countries. The BioProtect Balloon Implant™ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer. In creating this space, the BioProtect Balloon Implant™ System intends to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloon Implant™ System is a balloon made of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time.
From the manufacturer's own website. Source
What BioProtect makes
BioProtect manufactures the BioProtect Balloon Implant System, a biodegradable balloon designed to create and maintain space between the anterior rectal wall and the prostate during radiotherapy for prostate cancer. The device is intended to reduce radiation exposure to the anterior rectum while the patient undergoes treatment. Once the radiotherapy is complete, the balloon is absorbed by the patient’s body over time.
The BioProtect Balloon Implant System is classified as a Class III medical device and is registered in the EU’s eudamed database. The company is based in Israel.
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 manufacture?
BioProtect manufactures the BioProtect Balloon Implant System, a Class III medical device designed specifically for prostate cancer radiotherapy. This balloon, made from biodegradable material, temporarily positions the anterior rectal wall away from the prostate to reduce radiation exposure to the rectum during treatment. After radiotherapy, the balloon is absorbed by the patient’s body over time.
Where is BioProtect based, and where are its devices listed?
BioProtect is based in Israel. Its devices, including the BioProtect Balloon Implant System, are registered in the EU’s eudamed database, which is the official EU registry for medical devices. This registration reflects compliance with EU regulatory requirements for Class III devices.
How are BioProtect’s devices classified, and why does this matter?
The BioProtect Balloon Implant System is classified as a Class III medical device, the highest risk category under EU regulations. This classification is due to its intended use in radiotherapy for prostate cancer, where it directly influences patient safety and treatment outcomes. Class III devices require stringent regulatory oversight to ensure safety and performance before market placement.
What is the primary purpose of the BioProtect Balloon Implant System?
The BioProtect Balloon Implant System is designed to create and maintain a temporary space between the anterior rectal wall and the prostate during radiotherapy for prostate cancer. By doing so, it aims to reduce the radiation dose delivered to the anterior rectum, potentially lowering the risk of radiation-related side effects. The biodegradable balloon dissolves naturally after treatment is complete.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Israel
- Address
- 6, Ha’Gavish St., Netanya , Israel
- Website
- www.bioprotect.com
- linkedin.com/company/bioprotect-ltd
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Noga Avisar
- EUDAMED SRN
- IL-MF-000013165
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BioProtect Balloon Implant System | 0135 | EUDAMED | Class III | Active |
Related Companies
Authorised Representatives
- CEpartner4U NL
Importers
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Notified Bodies
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bioprotect Ltd US