Identity
- Trade Name
- Occlutech PDA Occluder Procedure Pack EUDAMED
- Device Name
- Occlutech PDA Occluder Procedure Pack EUDAMED
- Model / Reference
- 43PDA07LO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255888904612 EUDAMED
- Basic UDI-DI
- 426018252PDAOOP5U EUDAMED
- EMDN Code
- P07040303 CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Occlutech PDA Occluder is a percutaneous transcatheter medical device for the non-surgical closure of Patent Ductus Arteriosus (PDA). EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Occlutech PDA 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 | 426018252PDAOOP5U | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-PR-000049872
Sources (1)
- EUDAMED 79bc48bd-ae69-46fd-8160-ab3150f6b206 61 fields · synced Jun 19, 2026