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Occlutech Atrial Flow Regulator Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 65AFR10MF
Identity
- Trade Name
- Occlutech Atrial Flow Regulator Procedure Pack EUDAMED
- Device Name
- Occlutech® Atrial Flow Regulator (AFR) Procedure Pack EUDAMED
- Model / Reference
- 65AFR10MF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175601828 EUDAMED
- Basic UDI-DI
- 73401756AFRFLEXIIAK EUDAMED
- EMDN Code
- P0799 VASCULAR AND CARDIAC PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Occlutech AFR is a permanent cardiac implant intended to guard and secure the result of a Balloon Atrial Septostomy (BAS). EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Occlutech Atrial Flow Regulator 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 | 73401756AFRFLEXIIAK | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech International AB
- EUDAMED SRN
- SE-PR-000017759
Sources (1)
- EUDAMED 852cc935-1eb0-4237-a48c-5d77c776476b 61 fields · synced Jun 19, 2026