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SG Calibrator

by Sysmex Corporation

Ref CK-920-648

SG Calibrator (CK-920-648) is a device classified as IVD General made by Sysmex Corporation, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-04987562439898), 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-04987562439898 Basic UDI-DI 04987562439898UDI-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  • Withdrawn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
CK-920-648
Primary DI / UDI-DI
04987562439898
Basic UDI-DI
B-04987562439898
EMDN code
W0101060205 Urine multi-constituent test strips (automated)
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 URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED).

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)