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Cleaner 3000-6232

by EKF-diagnostic GmbH

Ref 3000-6232

Cleaner 3000-6232 is a device classified as Class A in the EU and Class II in the US made by EKF-diagnostic GmbH, registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 4048534AHAAVK) and listed in FDA GUDID since 21 Dec 2022 (UDI-DI 04048534000840), active as of 25 Oct 2026.

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

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4048534AHAAVK Basic UDI-DI 04048534000840UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048534000840 UDI-DI Date21 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048534AHAAVK registered 24 Jul 2026 Active
  • FDA GUDID UDI-DI 04048534000840 listed 21 Dec 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 04048534000840
  2. Registered EUDAMED 4048534AHAAVK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Cleaner
Generic name
Haemoglobin analyser IVD, point-of-care
Model / Ref / Catalog
3000-6232
Primary DI / UDI-DI
04048534000840
Basic UDI-DI
4048534AHAAVK
Unit of use DI
04048534002745
FDA product code
GKR, KHG
EMDN code
W0201010185 Chemistry analysers - consumables
GMDN term
Haemoglobin analyser IVD, point-of-care
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5620, 864.7500
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 A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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: Haemoglobin analyser IVD, point-of-care

Similar devices in this category

Other devices filed under CHEMISTRY ANALYSERS - CONSUMABLES.

Other devices from EKF-diagnostic GmbH

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Properties

  • Single use
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)