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Occlutech Atrial Flow Regulator Procedure Pack

EUDAMED

Class III (EU MDR)

Ref 65AFR10LFRef 65AFR10LPRef 65AFR10MFRef 65AFR08LFRef 65AFR08MFRef 65AFR08MP

by Occlutech GmbH

Identity

Trade Name
Occlutech Atrial Flow Regulator Procedure Pack EUDAMED
Device Name
Occlutech Atrial Flow Regulator Procedure Pack EUDAMED
Model / Reference
65AFR10LF EUDAMED
65AFR10LP EUDAMED
65AFR10MF EUDAMED
65AFR08LF EUDAMED
65AFR08MF EUDAMED
65AFR08MP EUDAMED

Identifiers

Primary DI / UDI-DI
04260182524862 EUDAMED
04260182524893 EUDAMED
04260182524978 EUDAMED
04260182524589 EUDAMED
04260182524701 EUDAMED
04260182524732 EUDAMED
Basic UDI-DI
426018252AFRFLEXIIZR EUDAMED
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

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Manufacturer

Manufacturer
Occlutech GmbH
EUDAMED SRN
DE-PR-000049872

Sources (6)

  • EUDAMED 10ce6195-5756-424b-8975-ee7708a7a15d 61 fields · synced Jul 17, 2026
  • EUDAMED 2a1f558c-375b-4500-8d0f-8c5b96a2c3da 61 fields · synced May 16, 2026
  • EUDAMED 6ad2da58-26e2-4a5a-a203-01e574054dde 61 fields · synced May 16, 2026
  • EUDAMED 55b5f32b-63fe-4e93-8419-758440257b79 61 fields · synced May 19, 2026
  • EUDAMED b35e5c9a-d582-4c4f-9345-a0c7e025ab06 61 fields · synced May 19, 2026
  • EUDAMED a6d949a1-ac63-4788-bc28-8a873719a4da 61 fields · synced May 19, 2026