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Occlutech Paravalvular Leak Device Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 63PLD12TF
Identity
- Trade Name
- Occlutech Paravalvular Leak Device Procedure Pack EUDAMED
- Device Name
- Occlutech Paravalvular Leak Device Procedure Pack EUDAMED
- Model / Reference
- 63PLD12TF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175601323 EUDAMED
- Basic UDI-DI
- 73401756PLDFLEXIZH EUDAMED
- EMDN Code
- P07040399 HEART AND CORONARY DEFECT OCCLUDERS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Occlutech PLD is a permanent cardiac implant intended to close a paravalvular leak (PVL). EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Occlutech Paravalvular Leak Device Procedure Pack by Occlutech International AB — 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 | 73401756PLDFLEXIZH | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech International AB
- EUDAMED SRN
- SE-PR-000017759
Sources (1)
- EUDAMED 5ecb60ff-dbf5-42e4-8976-45dd822d3503 61 fields · synced Jun 18, 2026