Identity
- Trade Name
- ACTIV Vacuum Erection System EUDAMED
- Device Name
- ACTIV Vacuum Erection System EUDAMED
- Model / Reference
- Ves-1314 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003967178 EUDAMED
- Basic UDI-DI
- 8964003967Ves-1314UJ EUDAMED
- EMDN Code
- P080202 PENILE PROSTHESES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ACTIV Vacuum Erection System by Ves-Vacuum International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8964003967Ves-1314UJ | Class I | Active |
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Manufacturer
- Manufacturer
- Ves-Vacuum International
- EUDAMED SRN
- PK-MF-000040378
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 0dada716-9aeb-4e2c-b022-245cd91e0214 61 fields · synced Jul 9, 2026