← Back to catalogue
INTELLAGEN™ Foot Pedal
EUDAMEDFDA UDIClass I (EU MDR)
Ref 20010Model G4 Foot Pedal
Identity
- Trade Name
- INTELLAGEN™ Foot Pedal EUDAMEDFDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- INTELLAGEN™ Foot Pedal EUDAMED
- Model / Reference
- G4 Foot Pedal EUDAMED20010 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- M004GEN100200100 FDA UDI
- Primary DI / UDI-DI
- 04260166373066 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260166370105051001ZM EUDAMED
- Direct Marketing DI
- 04260166373066 EUDAMED
- FDA Product Code
- OAD FDA UDILPB FDA UDI
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
- GMDN Term
- Foot-switch, electrical 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
INTELLAGEN™ 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 | 4260166370105051001ZM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-MF-000006981
Sources (2)
- EUDAMED b5d7c69e-444d-48af-a594-1a0916a82939 61 fields · synced Jun 19, 2026
- FDA UDI 7e713e70-84c8-4522-982a-832fa1c6c6b3 35 fields · synced May 30, 2026