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Occlutech PDA Occluder Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 42PDA15ORef 43PDA08LORef 43PDA06LORef 42PDA05ORef 42PDA06ORef 42PDA18O
Identity
- Trade Name
- Occlutech PDA Occluder Procedure Pack EUDAMED
- Device Name
- Occlutech PDA Occluder Procedure Pack EUDAMED
- Model / Reference
- 42PDA15O EUDAMED43PDA08LO EUDAMED43PDA06LO EUDAMED42PDA05O EUDAMED42PDA06O EUDAMED42PDA18O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255888903936 EUDAMED04255888904780 EUDAMED04255888904445 EUDAMED04255888902915 EUDAMED04255888903080 EUDAMED04255888904100 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 (6)
- EUDAMED e1dfb29e-10db-488f-9f56-c6e9feb7c696 61 fields · synced Sep 17, 2026
- EUDAMED db06575b-39a2-4425-988c-fa897b301910 61 fields · synced May 17, 2026
- EUDAMED af4fa12a-8f71-4e70-980b-f3a478a3a970 61 fields · synced May 17, 2026
- EUDAMED 34d76451-1f9e-4b35-88d1-d1b2146c2c1e 61 fields · synced May 18, 2026
- EUDAMED d5ca4092-02bb-4177-8b37-fca899d97584 61 fields · synced May 19, 2026
- EUDAMED 5e957e27-2bf9-4c78-9d3e-a922b1406e19 61 fields · synced May 19, 2026