Identity
- Trade Name
- Occlutech PDA Occluder Procedure Pack EUDAMED
- Device Name
- Occlutech PDA Occluder Procedure PacK EUDAMED
- Model / Reference
- 42PDA08O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175605024 EUDAMED
- Basic UDI-DI
- 73401756PDAOOPJP 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 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 | 73401756PDAOOPJP | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech International AB
- EUDAMED SRN
- SE-PR-000017759
Sources (1)
- EUDAMED 4f80a162-348f-4c61-909d-cb9b1e9205fc 61 fields · synced Jun 17, 2026