Skip to content

Portable automatic multifunctional analyzer KDS-D5000\ KDS-D6000\ KDS-D8000

by Jiangsu Confidence Medical Technology Co., Ltd

Ref KDS-Y100 \KDS-Y200 \KDS-Y500 \KDS-Y600 \KDS-Y800 \KDS-Y900

Active European Union

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69793559219YQ03JZ Basic UDI-DI 06979355922301UDI-DIDate30 Dec 2025RegisteredStatusActive

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  • Withdrawn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
Portable automatic multifunctional analyzer KDS-D5000\ KDS-D6000\ KDS-D8000
Model / Reference
KDS-Y100 \KDS-Y200 \KDS-Y500 \KDS-Y600 \KDS-Y800 \KDS-Y900
Primary DI / UDI-DI
06979355922301
Basic UDI-DI
69793559219YQ03JZ
Direct Marketing DI
06979355922301
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050949
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

Other devices from Jiangsu Confidence Medical Technology Co., Ltd

See all devices from Jiangsu Confidence Medical Technology Co., Ltd →

Properties

  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No