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Erbe 10134-000

by Erbe Elektromedizin GmbH

Ref 10134-000

Erbe 10134-000 is a medical device (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories; EMDN category argon electrosurgical units (esu)) made by Erbe Elektromedizin GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-04050147000193), cleared under FDA 510(k) K024047 on 8 Jan 2003 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 04050147000193), active as of 25 Oct 2026.

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

CE MDR 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K024047

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-04050147000193 Basic UDI-DI 04050147000193UDI-DIDate13 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-04050147000193 Basic UDI-DI 04050147000193UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147000193 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK024047 Date8 Jan 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04050147000193 registered 13 May 2026 Active· +1 more in the status table
  • FDA 510(k) K024047 decided 8 Jan 2003 Active
  • FDA GUDID UDI-DI 04050147000193 listed 13 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K024047
  2. Listed FDA GUDID 04050147000193
  3. Registered EUDAMED B-04050147000193

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ERBE APC 2 (für VIO®) EUDAMED
Erbe GUDID
Generic name
Argon-enhanced electrosurgical system gas delivery unit
Device name
APC 2 Module
Model / Ref / Catalog
10134-000
Primary DI / UDI-DI
04050147000193
Basic UDI-DI
B-04050147000193, 4050147APC2-G6
Direct marketing DI
04050147000193
510(k) Number
FDA product code
GEI
EMDN code
Z12010903 Argon electrosurgical units (esu)
GMDN term
Argon-enhanced electrosurgical system gas delivery unit
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
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: Argon-enhanced electrosurgical system gas delivery unit

Cleared under the same submission (K024047)

Similar devices in this category

Other devices filed under ELECTROSURGICAL INSTRUMENTS.

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)