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Erbe 20150-301

by Erbe Elektromedizin GmbH

Ref 20150-301

Erbe 20150-301 is a device classified as Class IIa in the EU and Class II in the US made by Erbe Elektromedizin GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-04050147020184), cleared under FDA 510(k) K231023 on 15 Jun 2023 and listed in FDA GUDID since 16 Jan 2024 (UDI-DI 04050147020184), 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) K231023

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/MDD EUDAMED NumberB-04050147020184 Basic UDI-DI 04050147020184UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147020184 UDI-DI Date16 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231023 Date15 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04050147020184 registered 13 May 2026 Active
  • FDA 510(k) K231023 decided 15 Jun 2023 Active
  • FDA GUDID UDI-DI 04050147020184 listed 16 Jan 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231023
  2. Listed FDA GUDID 04050147020184
  3. Registered EUDAMED B-04050147020184

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  • Withdrawn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
Pumpeneinheit plus EUDAMED
Erbe GUDID
Generic name
Water jet knife system pump-cartridge
Device name
Pump cartridge for ERBEJET 2, SU
Model / reference
20150-301
Primary DI / UDI-DI
04050147020184
Basic UDI-DI
B-04050147020184
510(k) Number
FDA product code
FQH
EMDN code
Z120106 Hydrodissectors
GMDN term
Water jet knife system pump-cartridge
Device class
Class IIa 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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 pump-cartridge

Cleared under the same submission (K231023)

and 7 more cleared under K231023

Similar devices

Also classified as Water jet knife system pump-cartridge.

Similar devices in this category

Other devices filed under GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS.

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)