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Erbe 20183-053

by Erbe Elektromedizin GmbH

Part of a family of 7 devices: see the family page

Ref 20183-053

Erbe 20183-053 is an electrosurgical cable adaptor (EU MDR Class I; 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 4050147Adapter-HF-M6), cleared under FDA 510(k) K083452 on 31 Dec 2008 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 04050147002265), 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) K083452

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4050147Adapter-HF-M6 Basic UDI-DI 04050147002265UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147002265 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK083452 Date31 Dec 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4050147Adapter-HF-M6 registered 13 May 2026 Active
  • FDA 510(k) K083452 decided 31 Dec 2008 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04050147002265 listed 22 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K023886
  2. Cleared FDA 510(k) K083452
  3. Listed FDA GUDID 04050147002265
  4. Registered EUDAMED 4050147Adapter-HF-M6

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  • Withdrawn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
Bipolarer Adapter Gerät EUDAMED
Erbe GUDID
Generic name
Electrosurgical cable adaptor
Device name
Electrosurgical adapter
Model / Ref / Catalog
20183-053
Primary DI / UDI-DI
04050147002265
Basic UDI-DI
4050147Adapter-HF-M6
Direct marketing DI
04050147002265
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

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 (K023886)

Cleared under the same submission (K083452)

and 8 more cleared under K083452

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

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