Identity
- Trade Name
- Einpedal-Fußschalter; VIO® 3 EUDAMEDERBE FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Footswitch, electrosurgery stystems EUDAMED
- Model / Reference
- 20188-350 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 20188-350 FDA UDI
- Primary DI / UDI-DI
- 04050147015708 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050147015708 EUDAMED
- 510(k) Number
- K190823 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class IIb 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Erbe by Erbe Elektromedizin GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K190823 also covers:
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
Sources (2)
- FDA UDI b0848dde-ef55-4201-81d2-691a4633d67f 36 fields · synced Jul 15, 2026
- EUDAMED 06e2ecc9-902c-4de3-be0f-6c8536a937f8 61 fields · synced Jul 15, 2026