Identity
- Trade Name
- Vaginaldehner Neovagina soft 28 x 140mm EUDAMED
- Device Name
- Vaginaldehner Neovagina soft 28 x 140mm EUDAMED
- Model / Reference
- MED1000650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250201203021 EUDAMED
- Basic UDI-DI
- 425020120302Y8 EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Zur konservativen Therapie in der Gynäkologie, z.B. bei Verengung des Scheideneingangs und des vaginalen bereichs (Vulva und Vagina) zur Vermeidung einer entsprechenden Operation. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Vaginaldehner Neovagina soft 28 x 140mm by medesign I.C. GmbH — 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 | 425020120302Y8 | Class I | Active |
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Manufacturer
- Manufacturer
- medesign I.C. GmbH
- EUDAMED SRN
- DE-PR-000040872
Sources (1)
- EUDAMED 33f43276-01a5-42b7-b5d5-2facac3e0cbc 61 fields · synced Jun 17, 2026