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SmartAblate™ Foot Pedal
EUDAMEDFDA UDIClass I (EU MDR)
Ref M490005Model G4 Foot Pedal
Identity
- Trade Name
- SmartAblate™ Foot Pedal EUDAMEDSmartAblateTM System Foot Pedal FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- SMARTABLATE™ Foot Pedal EUDAMED
- Model / Reference
- G4 Foot Pedal EUDAMEDM490005 EUDAMED02 FDA UDI
Identifiers
- Catalog Number
- M490005 FDA UDI
- Primary DI / UDI-DI
- 04260166371475 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260166370105011001Y9 EUDAMED
- Direct Marketing DI
- 04260166371475 EUDAMED
- FDA Product Code
- LPB FDA UDI
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SmartAblate™ Foot Pedal by Stockert GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260166370105011001Y9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-MF-000006981
Sources (2)
- EUDAMED 1c95d228-aabe-4fe8-b76c-c5f3b60536d7 61 fields · synced Jul 12, 2026
- FDA UDI 8c795c99-d163-4fda-b700-23f822f185be 33 fields · synced May 30, 2026