Identity
- Trade Name
- Vivian Basic II Dilator Set EUDAMED
- Device Name
- Vivian Basic II Dilator Set EUDAMED
- Model / Reference
- MED1001557 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250201206916 EUDAMED
- Basic UDI-DI
- 425020120691ZG EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Für die Behandlung von Vaginismus,Dyspareunie, nach einem chirurgischen Eingriff oder nach einer Episiotomie (Dammschnitt). EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Vivian Basic II Dilator Set 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 | 425020120691ZG | Class I | Active |
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Manufacturer
- Manufacturer
- medesign I.C. GmbH
- EUDAMED SRN
- DE-PR-000040872
Sources (1)
- EUDAMED a6684eba-87e7-4e94-9f37-a80496f3c3c4 61 fields · synced Jun 18, 2026