Devices (same UDI-DI)
1
Certificates
1
Countries
13
Notified Bodies
1
Basic Information
- Primary DI
- 07798121800106
- Basic UDI-DI Code
- B-07798121800106
- Reference
- T-130
- 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
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ฑ๐ป Latvia
๐ณ๐ด Norway
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ฎ Slovenia
๐น๐ท Tรผrkiye
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