Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Footswitches EUDAMEDFOOTSWITCH 2 PEDALS L 5M FOR HF SURGERY GENERATOR 400KHZ, with fixed connection cable, reusable FDA UDI
- Model / Reference
- 10000201491 EUDAMED2260021 EUDAMEDFDA UDI
- Description
- FOOTSWITCH 2 PEDALS L 5M FOR HF SURGERY GENERATOR 400KHZ, with fixed connection cable, reusable FDA UDI
Identifiers
- Catalog Number
- 2260021 FDA UDI
- Primary DI / UDI-DI
- 04055207063330 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520719032020-0030888GV EUDAMED
- Direct Marketing DI
- 04055207063330 EUDAMED
- 510(k) Number
- K230194 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12020404 REMOTE CONTROL UNITS FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 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
No
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
Dimensions & Sizes
- Size
- Length — 5 Meter FDA UDI
Footswitches by Richard Wolf 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 | 405520719032020-0030888GV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 5749ec3c-e10b-49bf-9d93-2f9bdbd5f21a 61 fields · synced Jun 20, 2026
- FDA UDI cceb7c0e-f768-465a-b3d3-8bb87def6f25 37 fields · synced May 25, 2026