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Erbe 20150-236

by Erbe Elektromedizin GmbH

Ref 20150-236

Erbe 20150-236 is a device classified as Class IIb in the EU and Class II in the US made by Erbe Elektromedizin GmbH, registered in EUDAMED on 18 May 2026 (Basic UDI-DI B-04050147024106), cleared under FDA 510(k) K083608 on 26 Aug 2009 (1 earlier submission) and listed in FDA GUDID since 16 Dec 2016 (UDI-DI 04050147024106), active as of 23 Oct 2026.

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

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083608

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04050147024106 Basic UDI-DI 04050147024106UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147024106 UDI-DI Date16 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083608 Date26 Aug 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04050147024106 registered 18 May 2026 Active
  • FDA 510(k) K083608 decided 26 Aug 2009 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04050147024106 listed 16 Dec 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K072404
  2. Cleared FDA 510(k) K083608
  3. Listed FDA GUDID 04050147024106
  4. Registered EUDAMED B-04050147024106

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Applikator;gerade; monopolar EUDAMED
Erbe GUDID
Generic name
Water jet knife system handpiece, single-use
Device name
Monopolar applicators, SU
Model / Ref / Catalog
20150-236
Primary DI / UDI-DI
04050147024106
Basic UDI-DI
B-04050147024106
510(k) Number
FDA product code
FQH
EMDN code
K0201010301 Open electrosurgery electrodes, single-use
GMDN term
Water jet knife system handpiece, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
880.5475
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 6.000 Millimeter
Length — 80.000 Millimeter

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: Water jet knife system handpiece, single-use

Cleared under the same submission (K072404)

and 8 more cleared under K072404

Cleared under the same submission (K083608)

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE.

Other devices from Erbe Elektromedizin GmbH

See all devices from Erbe Elektromedizin GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)