Identity
- Trade Name
- Softilate Vaginal Dilators EUDAMED
- Device Name
- Softilate Vaginal Dilators EUDAMED
- Model / Reference
- Ves-209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003967062 EUDAMED
- Basic UDI-DI
- 8964003967Ves-209GX EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE 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
Softilate Vaginal Dilators 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-209GX | 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 dd14fd7f-ea26-4991-ac09-f072b3b25cf8 61 fields · synced Jun 20, 2026