Identity
- Trade Name
- Vaginaldehner Hartkunststoff 6 x140 mm EUDAMED
- Device Name
- Vaginaldehner Hartkunststoff 6 x140 mm EUDAMED
- Model / Reference
- MED1000828 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250201203755 EUDAMED
- Basic UDI-DI
- 425020120375Z3 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 Hartkunststoff 6 x140 mm 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 | 425020120375Z3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- medesign I.C. GmbH
- EUDAMED SRN
- DE-PR-000040872
Sources (1)
- EUDAMED b4694b4d-12e0-4b48-a289-07f7cef8e270 61 fields · synced Jun 18, 2026