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INTELLAGEN™ RF Generator Kit
EUDAMEDClass IIb (EU MDR)
Ref 19939Model INTELLAGEN™ RF Generator Kit
Identity
- Trade Name
- INTELLAGEN™ RF Generator Kit EUDAMED
- Model / Reference
- INTELLAGEN™ RF Generator Kit EUDAMED19939 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260166373295 EUDAMED
- Basic UDI-DI
- 4260166370101053001XX 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™ RF Generator 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 | 4260166370101053001XX | Class IIb | Active |
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Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-PR-000033120
Sources (1)
- EUDAMED e041f885-8724-469b-9bf0-5a0f0b51d277 61 fields · synced Jul 11, 2026