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Erbe 10140-500

by Erbe Elektromedizin GmbH

Ref 10140-500

Erbe 10140-500 is an electrosurgical system generator (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Erbe Elektromedizin GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 4050147VIO-C-JR), cleared under FDA 510(k) K101108 on 16 Jul 2010 and listed in FDA GUDID since 10 Sep 2016 (UDI-DI 04050147009905), active as of 23 Oct 2026.

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

CE MDR 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) K101108

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/MDR EUDAMED Number4050147VIO-C-JR Basic UDI-DI 04050147009905UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147009905 UDI-DI Date10 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK101108 Date16 Jul 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4050147VIO-C-JR registered 13 May 2026 Active
  • FDA 510(k) K101108 decided 16 Jul 2010 Active
  • FDA GUDID UDI-DI 04050147009905 listed 10 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K101108
  2. Listed FDA GUDID 04050147009905
  3. Registered EUDAMED 4050147VIO-C-JR

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Erbe Vio® 100 C EUDAMED
Erbe GUDID
Generic name
Electrosurgical system generator
Device name
VIO C electrosurgical unit
Model / Ref / Catalog
10140-500
Primary DI / UDI-DI
04050147009905
Basic UDI-DI
4050147VIO-C-JR
Direct marketing DI
04050147009905
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Electrosurgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
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: Electrosurgical system generator

Cleared under the same submission (K101108)

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
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)