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Occlutech Atrial Flow Regulator Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 65AFR08LP
Identity
- Trade Name
- Occlutech Atrial Flow Regulator Procedure Pack EUDAMED
- Device Name
- Occlutech Atrial Flow Regulator Procedure Pack EUDAMED
- Model / Reference
- 65AFR08LP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182524619 EUDAMED
- Basic UDI-DI
- 426018252AFRPP2X EUDAMED
- EMDN Code
- P0799 VASCULAR AND CARDIAC PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Occlutech Atrial Flow Regulator is a permanent cardiac implant intended to guard and secure the result of a Balloon Atrial Septostomy. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Occlutech Atrial Flow Regulator 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 | 426018252AFRPP2X | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-PR-000049872
Sources (1)
- EUDAMED 5704008e-c966-48a7-b24d-3d416ad06525 61 fields · synced Jun 17, 2026