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Ca Clean I

by Sysmex Corporation

Ref 964-0631-3

Ca Clean I (964-0631-3) is a Class A device made by Sysmex Corporation, registered in EUDAMED on 5 Sep 2023 (Basic UDI-DI 4987562CACLEANI6U), active as of 24 Oct 2026.

Active European Union

CE IVDR

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/IVDR Number4987562CACLEANI6U Basic UDI-DI Date5 Sep 2023RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / reference
964-0631-3
Primary DI / UDI-DI
14987562509536, 14987562517005
Basic UDI-DI
4987562CACLEANI6U
EMDN code
W0103020999 Auxiliary reagents (haemostasis) - other
Device class
Class A
EU registration type
Standard device
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 AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER.

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

  • Reagent
  • Professional testing
Other properties (11, all answered No)