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Footswitches for control units
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2305100Model 10000201467
Identity
- Trade Name
- POWERSPEED AS1 FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Footswitches for control units EUDAMEDREMOTE FOOTSWITCH 2 PEDALS+2 BUTTONS for PowerSpeed AS1 Motor Control Unit, with optional backup cable FDA UDI
- Model / Reference
- 10000201467 EUDAMED2305100 EUDAMEDFDA UDI
- Description
- REMOTE FOOTSWITCH 2 PEDALS+2 BUTTONS for PowerSpeed AS1 Motor Control Unit, with optional backup cable FDA UDI
Identifiers
- Catalog Number
- 2305100 FDA UDI
- Primary DI / UDI-DI
- 04055207054765 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0028560PY EUDAMED
- Direct Marketing DI
- 04055207054765 EUDAMED
- FDA Product Code
- GEY 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 EUDAMEDFDA UDI
- Regulation Number
- 878.4820 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Footswitches for control units 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 | 405520727052019-0028560PY | 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 3e7809e1-2325-40c1-9f73-1322a03132b6 61 fields · synced Jul 23, 2026
- FDA UDI 33865781-b01d-49a5-a26a-d0c271a7c7eb 36 fields · synced May 30, 2026