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Erbe 10325-000

by Erbe Elektromedizin GmbH

Ref 10325-000

Erbe 10325-000 is a surgical irrigation/aspiration pump (EU MDD Class IIa; FDA Class II; FDA product code FQH, Lavage, Jet) made by Erbe Elektromedizin GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-04050147000292) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04050147000292), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04050147000292 Basic UDI-DI 04050147000292UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147000292 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04050147000292 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 04050147000292 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04050147000292
  2. Registered EUDAMED B-04050147000292

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Erbe Eip 2 EUDAMED
Erbe GUDID
Generic name
Surgical irrigation/aspiration pump, reusable
Device name
EIP 2 irrigation pump
Model / reference
10325-000
Primary DI / UDI-DI
04050147000292
Basic UDI-DI
B-04050147000292
FDA product code
FQH
EMDN code
Z12019007 Irrigators
GMDN term
Surgical irrigation/aspiration pump, reusable
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: Surgical irrigation/aspiration pump, reusable

Similar devices in this category

Other devices filed under IRRIGATORS.

Other devices from Erbe Elektromedizin GmbH

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)