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Occlutech Paravalvular Leak Device Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 61PLD14WFRef 63PLD07TPRef 62PLD03TPRef 62PLD03TFRef 62PLD05TPRef 63PLD05TPRef 61PLD12WFRef 61PLD06WPRef 61PLD16WFRef 60PLD07WFRef 63PLD10TPRef 61PLD12WPRef 61PLD16WPRef 60PLD07WPRef 62PLD05TFRef 61PLD10WPRef 62PLD07TPRef 60PLD04WFRef 63PLD10TFRef 61PLD04WPRef 63PLD12TPRef 61PLD10WFRef 60PLD06WFRef 60PLD05WPRef 61PLD18WPRef 60PLD05WFRef 61PLD14WPRef 61PLD08WFRef 60PLD05WPRef 62PLD07TFRef 61PLD06WFRef 61PLD08WPRef 61PLD04WF
Identity
- Trade Name
- Occlutech Paravalvular Leak Device Procedure Pack EUDAMED
- Device Name
- Occlutech Paravalvular Leak Device Procedure Pack EUDAMED
- Model / Reference
- 61PLD14WF EUDAMED63PLD07TP EUDAMED62PLD03TP EUDAMED62PLD03TF EUDAMED62PLD05TP EUDAMED63PLD05TP EUDAMED61PLD12WF EUDAMED61PLD06WP EUDAMED61PLD16WF EUDAMED60PLD07WF EUDAMED63PLD10TP EUDAMED61PLD12WP EUDAMED61PLD16WP EUDAMED60PLD07WP EUDAMED62PLD05TF EUDAMED61PLD10WP EUDAMED62PLD07TP EUDAMED60PLD04WF EUDAMED63PLD10TF EUDAMED61PLD04WP EUDAMED63PLD12TP EUDAMED61PLD10WF EUDAMED60PLD06WF EUDAMED60PLD05WP EUDAMED61PLD18WP EUDAMED60PLD05WF EUDAMED61PLD14WP EUDAMED61PLD08WF EUDAMED62PLD07TF EUDAMED61PLD06WF EUDAMED61PLD08WP EUDAMED61PLD04WF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175601231 EUDAMED07340175601736 EUDAMED07340175601699 EUDAMED07340175601262 EUDAMED07340175601705 EUDAMED07340175603945 EUDAMED07340175604546 EUDAMED07340175601620 EUDAMED07340175604560 EUDAMED07340175601170 EUDAMED07340175603969 EUDAMED07340175604584 EUDAMED07340175601651 EUDAMED07340175603891 EUDAMED07340175601606 EUDAMED07340175601279 EUDAMED07340175603860 EUDAMED07340175603938 EUDAMED07340175601149 EUDAMED07340175604492 EUDAMED07340175604638 EUDAMED07340175603839 EUDAMED07340175601750 EUDAMED07340175601217 EUDAMED07340175601613 EUDAMED07340175604485 EUDAMED07340175601163 EUDAMED07340175601316 EUDAMED07340175601583 EUDAMED07340175603907 EUDAMED07340175601156 EUDAMED07340175601668 EUDAMED07340175604522 EUDAMED07340175603808 EUDAMED07340175601286 EUDAMED07340175601248 EUDAMED07340175601194 EUDAMED07340175601224 EUDAMED07340175603921 EUDAMED07340175601637 EUDAMED07340175604607 EUDAMED07340175604508 EUDAMED07340175601675 EUDAMED07340175603877 EUDAMED07340175604553 EUDAMED07340175604461 EUDAMED07340175603952 EUDAMED
- Basic UDI-DI
- 73401756PLDFLEXIZH EUDAMED73401756PLDPPMR 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 (47)
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