Identity
- Trade Name
- Occlutech mVSD Occluder Procedure Pack EUDAMED
- Device Name
- Occlutech mVSD Occluder Procedure Pack EUDAMED
- Model / Reference
- 71VSD16F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182525739 EUDAMED
- Basic UDI-DI
- 426018252MVSDFLEXII9X EUDAMED
- EMDN Code
- P07040301 CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- Occlutech Muscular VSD Occluder is percutaneous, transcatheter muscular ventricular septal defect closure device designed for the occlusion of haemodynamically significant muscular ventricular septal defects. It is deployed via a minimally invasive catheter delivery system technique. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Occlutech mVSD Occluder Procedure Pack by Occlutech GmbH — Class III — 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 | 426018252MVSDFLEXII9X | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-PR-000049872
Sources (1)
- EUDAMED 499c4d89-b470-45cf-977c-e1059cd39ba5 61 fields · synced Jun 18, 2026