Identity
- Trade Name
- EasyControl 90G8 S EUDAMED
- Device Name
- EasyControl 90G8 S EUDAMED
- Model / Reference
- MF0021 EUDAMED105-451 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255650100600 EUDAMED
- Basic UDI-DI
- B-04255650100600 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
EasyControl 90G8 S by MedFact Engineering GmbH — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system catheter.
- INTELLANAV STABLEPOINT™ — Boston Scientific · Class III
- Blazer® II XP — Boston Scientific · Class III
- Celsius — Biosense Webster Inc · Class II
- ThermoCool SF — Biosense Webster Inc · Class III
- EZ Steer DS — Biosense Webster Inc · Class III
- Livewire™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION · Class III
- EZ Steer — Biosense Webster Inc · Class III
- NaviStar DS — Biosense Webster Inc · Class III
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-04255650100600 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MedFact Engineering GmbH
- EUDAMED SRN
- DE-MF-000010098
Sources (1)
- EUDAMED 472d9a35-dcf2-46d9-ab5d-867b40cd3bd6 61 fields · synced Jun 11, 2026