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Platelet CHECK

by Sysmex Corporation 2 variants

Ref CN464998

Platelet CHECK (CN464998) is a device classified as IVD General made by Sysmex Corporation, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-04987562507993), 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-04987562507993 Basic UDI-DI 04987562507993UDI-DIDate6 Oct 2026RegisteredStatusActive

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  • Withdrawn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
CN464998
Primary DI / UDI-DI
04987562507993
Basic UDI-DI
B-04987562507993
EMDN code
W0103010505 Platelet controls
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

Similar devices in this category

Other devices filed under HAEMATOLOGY CONTROLS AND CALIBRATORS.

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
Other properties (8, all answered No)