← Back to catalogue
INTELLAGEN™ Irrigation Pump Kit
EUDAMEDClass IIa (EU MDR)
Ref 19940Model INTELLAGEN™ Irrigation Pump Kit
Identity
- Trade Name
- INTELLAGEN™ Irrigation Pump Kit EUDAMED
- Model / Reference
- INTELLAGEN™ Irrigation Pump Kit EUDAMED19940 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260166373356 EUDAMED
- Basic UDI-DI
- 4260166370103053001YZ EUDAMED
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- System is intended to work in conjunction with the INTELLAGEN™ RF Generator to deliver irrigation solution at specified flow rates to irrigated catheters for cooling purposes according to the indications defined for the respective applied part (ablation catheters). The system is used with the compatible lrrigation Tubing Set that conducts the irrigation solution from an external source to the compatible irrigated catheters. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
INTELLAGEN™ Irrigation Pump Kit by Stockert GmbH — Class IIa — 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 | 4260166370103053001YZ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-PR-000033120
Sources (1)
- EUDAMED 9506c954-6b9e-43bd-bd0a-79c99a0911c5 61 fields · synced Jul 9, 2026