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Occlutech Paravalvular Leak Device Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 61PLD12WF
Identity
- Trade Name
- Occlutech Paravalvular Leak Device Procedure Pack EUDAMED
- Device Name
- Occlutech Paravalvular Leak Device Procedure Pack EUDAMED
- Model / Reference
- 61PLD12WF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182523551 EUDAMED
- Basic UDI-DI
- 426018252PLDFLEXIRC EUDAMED
- EMDN Code
- P07040399 HEART AND CORONARY DEFECT OCCLUDERS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Occlutech PLD Occluder is a closure device. It is intended for closure of paravalvular leak and is implanted via percutaneous catheter interventional procedure. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Occlutech Paravalvular Leak Device 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 | 426018252PLDFLEXIRC | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-PR-000049872
Sources (1)
- EUDAMED 5451fb2c-8fea-4e2f-bbd1-8211950fd77c 61 fields · synced Jun 18, 2026