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Erbe 10140-200

by Erbe Elektromedizin GmbH

Ref 10140-200

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-04050147000216 Basic UDI-DI 04050147000216UDI-DIDate13 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-04050147000216 Basic UDI-DI 04050147000216UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147000216 UDI-DI Date10 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Erbe Vio® 200 D EUDAMED
Erbe GUDID
Generic Name
Electrosurgical system generator
Device Name
VIO D/S electrosurgical units
Model / Ref / Catalog
10140-200
Primary DI / UDI-DI
04050147000216
Basic UDI-DI
B-04050147000216, 4050147VIO2-PQ
Direct Marketing DI
04050147000216
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 market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K083452)

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No