Identity
- Trade Name
- Pelvimed Dilator Set EUDAMED
- Device Name
- Pelvimed Dilator Set EUDAMED
- Model / Reference
- MED1002643 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250201226365 EUDAMED
- Basic UDI-DI
- 425020122636ZN EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Zur konservativen Therapie in der Gynäkplogie, z.B. bei Verengungdes Scheideneingangs und des vaginalen Bereichs ( Vulva und Vagina) zur Vermeidung einer entsprechenden Operation. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Pelvimed 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 | 425020122636ZN | Class I | Active |
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Manufacturer
- Manufacturer
- medesign I.C. GmbH
- EUDAMED SRN
- DE-PR-000040872
Sources (1)
- EUDAMED ea39ad36-0c0a-48cc-bc32-ca1d84d3c4bf 61 fields · synced Jul 8, 2026