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INTELLAGEN™ Remote Control Kit
EUDAMEDClass IIb (EU MDR)
Ref 19941Model INTELLAGEN™ Remote Control Kit
Identity
- Trade Name
- INTELLAGEN™ Remote Control Kit EUDAMED
- Model / Reference
- INTELLAGEN™ Remote Control Kit EUDAMED19941 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260166373332 EUDAMED
- Basic UDI-DI
- 4260166370102053001YG EUDAMED
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- System is intended for use during RF ablation therapy of the human heart according to the indications defined for the respective applied part (ablation catheters). EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
INTELLAGEN™ Remote Control Kit by Stockert GmbH — Class IIb — 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 | 4260166370102053001YG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-PR-000033120
Sources (1)
- EUDAMED e9a68397-c5e3-4995-a5f2-4b6c850a2965 61 fields · synced Jun 20, 2026