Identity
- Trade Name
- EasyCool 80G4 S EUDAMED
- Device Name
- EasyCool 80G4 S EUDAMED
- Model / Reference
- MF0026 EUDAMED105-418 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255650100655 EUDAMED
- Basic UDI-DI
- B-04255650100655 EUDAMED
- EMDN Code
- C020301 ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Cardiac radio-frequency ablation system catheter
EasyCool 80G4 S by MedFact Engineering GmbH — 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-04255650100655 | Class III | Active |
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Manufacturer
- Manufacturer
- MedFact Engineering GmbH
- EUDAMED SRN
- DE-MF-000010098
Sources (1)
- EUDAMED ade859b6-c332-4f5d-98db-da53ac899e2d 61 fields · synced Oct 6, 2026