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Sample Plate, Sap-400A

by Sysmex Corporation

Ref 974-0771-3Model SAP-400A

Sample Plate, Sap-400A (974-0771-3) is a Class A device made by Sysmex Corporation, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 4987562SAMPLEPLATEK7), 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 Number4987562SAMPLEPLATEK7 Basic UDI-DI 04987562201297UDI-DIDate5 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device name
Sample Plate
Model / reference
SAP-400A, 974-0771-3
Primary DI / UDI-DI
04987562201297
Basic UDI-DI
4987562SAMPLEPLATEK7
EMDN code
W0503010203 Samples analyses, plastic cuvettes
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

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Properties

  • Professional testing
Other properties (12, all answered No)