Skip to content

Erbe 20189-350

by Erbe Elektromedizin GmbH

Ref 20189-350

Erbe 20189-350 is a device classified as Class IIb in the EU and Class II in the US made by Erbe Elektromedizin GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-04050147015746), cleared under FDA 510(k) K190823 on 22 May 2019 and listed in FDA GUDID since 18 Oct 2019 (UDI-DI 04050147015746), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190823

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04050147015746 Basic UDI-DI 04050147015746UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147015746 UDI-DI Date18 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190823 Date22 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04050147015746 registered 13 May 2026 Active
  • FDA 510(k) K190823 decided 22 May 2019 Active
  • FDA GUDID UDI-DI 04050147015746 listed 18 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190823
  2. Listed FDA GUDID 04050147015746
  3. Registered EUDAMED B-04050147015746

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Zweipedal-Fußschalter; VIO® 3 EUDAMED
Erbe GUDID
Generic name
Foot-switch, electrical
Device name
Footswitch, electrosurgery stystems
Model / Ref / Catalog
20189-350
Primary DI / UDI-DI
04050147015746
Basic UDI-DI
B-04050147015746
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Foot-switch, electrical
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Foot-switch, electrical

Cleared under the same submission (K190823)

and 8 more cleared under K190823

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Erbe Elektromedizin GmbH

See all devices from Erbe Elektromedizin GmbH →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)