Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records โ and cites every one.
Free to try ยท every answer cites its records
Basic Information
- Primary DI
- 07798121800090
- Basic UDI-DI Code
- B-07798121800090
- Reference
- T-120VS
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- PROMEDON S.A.
Additional Description
Designed for implantation into the penis, TUBE malleable penile prosthesis is advisable for all those patients who suffer from erectile impotence and who are considered candidates for surgical implants. The TUBE Penile prosthesis has been used for treatment of erectile impotence derived from various causes: spinal cord injuries, post-surgical lesions, multiple sclerosis, arteriosclerosis, arterial hypertension, and others. The prosthesis can also be used in selected patients with psychogenic impotence.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P080202 | PENILE PROSTHESES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | HD 60150769 0001 | TรV Rheinland LGA Products GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).