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Xn Check

by Sysmex Corporation 6 variants

Ref AE474952

Xn Check (AE474952) is a device classified as IVD General made by Sysmex Corporation, registered in EUDAMED on 10 Sep 2024 (Basic UDI-DI B-AE474952UF), active as of 24 Oct 2026.

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-AE474952UF Basic UDI-DI Date10 Sep 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
AE474952
Primary DI / UDI-DI
D-AE474952UF, 14987562461919
Basic UDI-DI
B-AE474952UF, B-14987562461919
EMDN code
W0103010599, W0103010503
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

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

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Properties

  • Contains human tissues or cells NoEUDAMEDYesEUDAMED
  • Contains animal tissues or cells NoEUDAMEDYesEUDAMED
  • Reagent
  • IVD kit YesEUDAMEDNoEUDAMED
  • Professional testing
Other properties (7, all answered No)