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Erbe 20132-158

by Erbe Elektromedizin GmbH

Ref 20132-158

Erbe 20132-158 is a device classified as Class I in the EU and Class II in the US made by Erbe Elektromedizin GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 4050147Cable-HF-WX), cleared under FDA 510(k) K013348 on 26 Oct 2001 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 04050147001145), 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) K013348

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 Number4050147Cable-HF-WX Basic UDI-DI 04050147001145UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147001145 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK013348 Date26 Oct 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4050147Cable-HF-WX registered 13 May 2026 Active
  • FDA 510(k) K013348 decided 26 Oct 2001 Active
  • FDA GUDID UDI-DI 04050147001145 listed 14 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K013348
  2. Listed FDA GUDID 04050147001145
  3. Registered EUDAMED 4050147Cable-HF-WX

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  • Withdrawn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
Anschlusskabel APC Sonde EUDAMED
Erbe GUDID
Generic name
Electrosurgical cable adaptor
Device name
Cable for electrosurgical unit
Model / Ref / Catalog
20132-158
Primary DI / UDI-DI
04050147001145
Basic UDI-DI
4050147Cable-HF-WX
Direct marketing DI
04050147001145
510(k) Number
FDA product code
GEI
EMDN code
K020180 Single- and bipolar devices, single use - accessories
GMDN term
Electrosurgical cable adaptor
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 2.500 Meter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 cable adaptor

Cleared under the same submission (K013348)

and 3 more cleared under K013348

Similar devices in this category

Other devices filed under SINGLE- AND BIPOLAR DEVICES, SINGLE USE - ACCESSORIES.

Other devices from Erbe Elektromedizin GmbH

See all devices from Erbe Elektromedizin GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)