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Occlutech Atrial Flow Regulator Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 65AFR08MFRef 65AFR10MPRef 65AFR10LFRef 65AFR08LPRef 65AFR08LFRef 65AFR08MPRef 65AFR10LP
Identity
- Trade Name
- Occlutech Atrial Flow Regulator Procedure Pack EUDAMED
- Device Name
- Occlutech® Atrial Flow Regulator (AFR) Procedure Pack EUDAMED
- Model / Reference
- 65AFR08MF EUDAMED65AFR10MP EUDAMED65AFR10LF EUDAMED65AFR08LP EUDAMED65AFR08LF EUDAMED65AFR08MP EUDAMED65AFR10LP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175601811 EUDAMED07340175603990 EUDAMED07340175601842 EUDAMED07340175601873 EUDAMED07340175604676 EUDAMED07340175601859 EUDAMED07340175603983 EUDAMED07340175604010 EUDAMED07340175604652 EUDAMED07340175601880 EUDAMED
- Basic UDI-DI
- 73401756AFRFLEXIIAK EUDAMED73401756AFRPPHG 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 (10)
- EUDAMED 003ebba1-33fd-4648-bb75-28f15b48da10 61 fields · synced Aug 1, 2026
- EUDAMED ed483dec-2a55-4855-a6a4-11ab2abbe104 61 fields · synced May 11, 2026
- EUDAMED d2fb9feb-79b4-4f40-9275-ee9ed21f28a2 61 fields · synced May 17, 2026
- EUDAMED 859ff256-4df1-4651-ae1e-44f389d1927e 61 fields · synced May 17, 2026
- EUDAMED 127671f7-6d90-46ea-b946-6fd1e429f1ea 61 fields · synced May 18, 2026
- EUDAMED 9586ad5c-0e5c-4374-9728-15c11296ce14 61 fields · synced May 18, 2026
- EUDAMED 86871f7c-090c-4dbf-984f-b7575de2efd3 61 fields · synced May 18, 2026
- EUDAMED 4d13299e-046b-4c26-9e51-babedf77ef55 61 fields · synced May 19, 2026
- EUDAMED 0195388f-f361-48df-9354-0d94c67bea27 61 fields · synced May 19, 2026
- EUDAMED 3effa947-4fdc-46a6-b356-6ae9a92f4dd2 61 fields · synced May 19, 2026