Eu Mdd
Eu Md Class 3
On The Market
๐ฎ๐ฑ Israel
Bioprotect Balloon Implant System
Devices (same UDI-DI)
1
Certificates
1
Countries
10
Notified Bodies
1
Basic Information
- Primary DI
- D-72900148787D
- Basic UDI-DI Code
- B-72900148787D
- Reference
- 0135
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- BioProtect
Additional Description
The BioProtect Balloonโข Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the BioProtect Balloonโข Implant System to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloonโข 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 patientโs body over time.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V9099 | VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 2116136CE01 | DEKRA Certification B.V. | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ฌ๐ง United Kingdom
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