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Fully Automated Urine Particle Digital Imaging Device UD-10

by Sysmex Corporation

Ref CJ445012Model UD-10

Fully Automated Urine Particle Digital Imaging Device UD-10 (CJ445012) is an urine analyser IVD (EU IVDR Class A; FDA Class II; FDA product code JOY, Device, Automated Cell-Locating) made by Sysmex Corporation, registered in EUDAMED on 10 Jun 2024 (Basic UDI-DI 4987562UD-1037) and listed in FDA GUDID since 11 Dec 2018 (UDI-DI 04987562444779), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4987562UD-1037 Basic UDI-DI 04987562444779UDI-DIDate10 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04987562444779 UDI-DI Date11 Dec 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4987562UD-1037 registered 10 Jun 2024 Active
  • FDA GUDID UDI-DI 04987562444779 listed 11 Dec 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04987562444779
  2. Registered EUDAMED 4987562UD-1037

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  • Withdrawn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
Urine analyser IVD, laboratory
Model / reference
UD-10, CJ445012
Primary DI / UDI-DI
04987562444779
Basic UDI-DI
4987562UD-1037
FDA product code
JOY
EMDN code
W0202050304 Digital laboratory microscopes
GMDN term
Urine analyser IVD, laboratory
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5260
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.

Manufacturer details

EUDAMED SRN
JP-MF-000014037
Authorised representative
Sysmex Europe SE DE-AR-000022333

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Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)