Identity
- Trade Name
- HELIOSTAR Balloon Ablation Catheter EUDAMED
- Model / Reference
- D138904 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000014219000001Q6 EUDAMED
- Basic UDI-DI
- B-USMF000014219000001Q6 EUDAMED
- EMDN Code
- C020301 ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Cardiac radio-frequency ablation system catheter
HELIOSTAR Balloon Ablation Catheter by Biosense Webster Inc — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cardiac radio-frequency ablation system catheter.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000014219000001Q6 | Class III | Active |
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Manufacturer
- Manufacturer
- Biosense Webster, Inc
- EUDAMED SRN
- US-MF-000014219
- Authorised Representative
- Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE-AR-000012231
Sources (1)
- EUDAMED 393b26a7-9440-4ab1-936a-4eeb2f44bb59 61 fields · synced Jul 18, 2026