Identity
- Trade Name
- Femsafe Bladder Support Device EUDAMED
- Device Name
- Femsafe Bladder Support Device EUDAMED
- Model / Reference
- Ves-338 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003967000 EUDAMED
- Basic UDI-DI
- 8964003967Ves-338HB EUDAMED
- EMDN Code
- P080199 URINARY INCONTINENCE PROSTHESES - OTHER 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
Femsafe Bladder Support Device 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-338HB | 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 8674abb8-e8b2-49a0-ab54-fbc5b848d747 61 fields · synced Jul 13, 2026