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Cleaner

by EKF-diagnostic GmbH

Ref 3000-6233

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

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number14048534002742 UDI-DI Date31 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number4048534AHAAVK Basic UDI-DI 14048534002742UDI-DIDate24 Jul 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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

Generic Name
Haemoglobin analyser IVD, point-of-care
Model / Ref / Catalog
3000-6233
Primary DI / UDI-DI
14048534002742
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
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006416

Other devices from Ekf Diagnostic GmbH

See all devices from Ekf Diagnostic GmbH →

Properties

  • Single Use
  • Near-Patient Testing
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No