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SA-10 Sampler Unit

by Sysmex Corporation 2 variants

Part of a family of 10 devices: see the family page

Ref CP366273

SA-10 Sampler Unit (CP366273) is a Class A device made by Sysmex Corporation, registered in EUDAMED on 29 Sep 2023 (Basic UDI-DI 4987562XNsamplerunitND), 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 Number4987562XNsamplerunitND Basic UDI-DI 04987562434114UDI-DIDate29 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  • Withdrawn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

Device name
Sampler Unit
Model / reference
CP366273
Primary DI / UDI-DI
04987562434114
Basic UDI-DI
4987562XNsamplerunitND
EMDN code
W02029080 Various hematology / histology / cytology instruments - hardware accessories
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 VARIOUS HEMATOLOGY / HISTOLOGY /CYTOLOGY INSTRUMENTS.

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

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