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Qtest K 0124

by Dfi Co., Ltd

Part of a family of 20 devices: see the family page

Ref 0124Model CYBOW Series

Qtest K 0124 is a device classified as Class B in the EU and Class I in the US made by Dfi Co., Ltd, registered in EUDAMED on 11 May 2026 (Basic UDI-DI 88061413US31D0JC) and listed in FDA GUDID since 14 Oct 2022 (UDI-DI 08806141304630), active as of 23 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number88061413US31D0JC Basic UDI-DI 08806141304630UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806141304630 UDI-DI Date14 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88061413US31D0JC registered 11 May 2026 Active
  • FDA GUDID UDI-DI 08806141304630 listed 14 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806141304630
  2. Registered EUDAMED 88061413US31D0JC

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  • Withdrawn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
Cybow K EUDAMED
Qtest K GUDID
Generic name
Urine ketone IVD, kit, rapid colorimetric, clinical
Device name
CYBOW Series
Model / reference
0124, CYBOW Series
Primary DI / UDI-DI
08806141304630 EUDAMED
08806141301592 GUDID
Basic UDI-DI
88061413US31D0JC
FDA product code
JIN
EMDN code
W01010999 Multiple parameters urine testing - other
GMDN term
Urine ketone IVD, kit, rapid colorimetric, clinical
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1435
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08806141304630
GUDID
08806141301592
Device classEUDAMED
Class B
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08806141304630; FDA GUDID lists 08806141301592), so their flags are not compared. Device class is stated on each registry's own scale: Class B in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Urine ketone IVD, kit, rapid colorimetric, clinical

Similar devices in this category

Other devices filed under MULTIPLE PARAMETERS URINE TESTING - OTHER.

Other devices from DFI Co., Ltd.

See all devices from DFI Co., Ltd. →

Properties

  • Single use
  • IVD kit
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)