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BioProtect

Active in EUDAMED
Also registered as BIOPROTECT LTD.

Israelfrom SRN EUDAMED FDA SRN IL-MF-000013165

BioProtect is a medical device manufacturer based in Israel, with 2 devices listed in EUDAMED and FDA 510(k) (EU Class III; FDA Class II) as of 13 Nov 2026.

Devices
2
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 1
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • EU Class III 1
  • FDA Class II 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN IL-MF-000013165

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA establishment
Authorised rep.
CEpartner4UNL

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.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
IL-MF-000013165
EU VAT number
513591396
EUDAMED status
Active
EUDAMED registered name
BioProtect
Registered address
6, Ha’Gavish St., 4250706, Netanya, Israel
PRRC contact
Noga Avisar(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 1 Aug 2029

EUDAMED certificates (2)

DEKRA Certification B.V. 0344 2 certificates

  • 3902997CE01 Active

    Quality management system EU MDR

    Issued
    14 Aug 2024
    Expires
    1 Aug 2029
  • 3902997TD01 Active

    Technical documentation EU MDR

    Issued
    14 Aug 2024
    Expires
    1 Aug 2029

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Bioprotect Ltd US

From the company website

Read 18 Sep 2026

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

Frequently asked questions

How many devices does BioProtect have in the registry?

The registry currently lists 2 devices for BioProtect. Devices recorded under merged duplicate company entries are counted once.

Which registries list BioProtect's devices?

Among its 2 most recently registered devices, BioProtect has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do BioProtect's devices fall under?

Among its 2 most recently registered devices, the classes recorded for BioProtect's devices are Class II and Class III. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for BioProtect?

EUDAMED lists 2 certificates for BioProtect (quality management system; technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 14 Aug 2024.

What are the newest devices from BioProtect in the registry?

The most recently registered devices listed for BioProtect include BioProtect Balloon Implant™ System and BioProtect Balloon Implant System.

Which FDA establishments are linked to BioProtect?

1 FDA establishment is linked to BioProtect in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.