Identity
- Trade Name
- Zweipedal-Fußschalter VIO® EUDAMEDERBE FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Footswitch, electrosurgery stystems EUDAMEDVIO® 2-pedal footswitch bracket; AP&IPX8 Equipment; US FDA UDI
- Model / Reference
- 20189-304 EUDAMEDFDA UDI
- Description
- VIO® 2-pedal footswitch bracket; AP&IPX8 Equipment; US FDA UDI
Identifiers
- Catalog Number
- 20189-304 FDA UDI
- Primary DI / UDI-DI
- 04050147015395 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050147015395 EUDAMED
- 510(k) Number
- K083452 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
Similar devices
Also classified as Foot-switch, electrical.
- ElectrodeCRF — Cambridge Interventional LLC · Class IIb
- ElectrodeCRF — Cambridge Interventional LLC · Class IIb
- Alligature-E — Alan Electronic Systems Private Limited · Class IIb
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · U
- Arthrex® — Arthrex, Inc. · Class I
- CableAME — Cambridge Interventional LLC · Class IIb
- CORE — Stryker Corp. · Class II
- PowerPack — MICROLINE SURGICAL, INC. · Class II
Cleared under the same submission
K083452 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
Sources (2)
- FDA UDI e37bcb3a-3d6c-4ca4-b9d8-96899474a765 37 fields · synced Jun 19, 2026
- EUDAMED 38f96374-4db0-44ec-b92e-6fb60bc65157 61 fields · synced Jun 19, 2026