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Erbe 10340-000

by Erbe Elektromedizin GmbH

Ref 10340-000

Erbe 10340-000 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 4050147ESM-2-DC), cleared under FDA 510(k) K231023 on 15 Jun 2023 (1 earlier submission) and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 04050147000322), 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) K231023

+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 Number4050147ESM-2-DC Basic UDI-DI 04050147000322UDI-DIDate13 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231023 Date15 Jun 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04050147000322 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4050147ESM-2-DC registered 13 May 2026 Active
  • FDA 510(k) K231023 decided 15 Jun 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04050147000322 listed 20 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K072404
  2. Listed FDA GUDID 04050147000322
  3. Cleared FDA 510(k) K231023
  4. Registered EUDAMED 4050147ESM-2-DC

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  • Withdrawn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
Erbe Esm 2 EUDAMED
Erbe GUDID
Generic name
Surgical irrigation/aspiration pump, reusable
Device name
ESM 2 suction module
Model / Ref / Catalog
10340-000
Primary DI / UDI-DI
04050147000322
Basic UDI-DI
4050147ESM-2-DC
Direct marketing DI
04050147000322
510(k) Number
FDA product code
FQH
EMDN code
Z120105 Surgical medical aspirators
GMDN term
Surgical irrigation/aspiration pump, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5475
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 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: Surgical irrigation/aspiration pump, reusable

Cleared under the same submission (K072404)

and 8 more cleared under K072404

Cleared under the same submission (K231023)

and 7 more cleared under K231023

Similar devices in this category

Other devices filed under SURGICAL MEDICAL ASPIRATORS.

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)