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Automatic Chemiluminescence Immunoassay Analyzer KDS-F1600\ KDS-F2600\ KDS-F3600\ KDS-F6600\ KDS-F8800\ KDS-F9900

by Jiangsu Confidence Medical Technology Co., Ltd

Ref KDS-F1600\ KDS-F2600\ KDS-F3600\ KDS-F6600\ KDS-F8800\ KDS-F9900, 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 Number69793559219YQ02JX Basic UDI-DI Date30 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  • Withdrawn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
Automatic Chemiluminescence Immunoassay Analyzer KDS-F1600\ KDS-F2600\ KDS-F3600\ KDS-F6600\ KDS-F8800\ KDS-F9900
Model / Reference
KDS-F1600\ KDS-F2600\ KDS-F3600\ KDS-F6600\ KDS-F8800\ KDS-F9900, KDS-Y100 \KDS-Y200 \KDS-Y500 \KDS-Y600 \KDS-Y800 \KDS-Y900
Primary DI / UDI-DI
06979355922181, 06979355922242
Basic UDI-DI
69793559219YQ02JX, 69793559219YQ01JV
Direct Marketing DI
06979355922181
06979355922242
EMDN Code
W01029099, W0599
Device Class
Class A
EU market of registration
Spain
Slovenia

Manufacturer details

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

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Properties

  • Professional Testing YesEUDAMEDNoEUDAMED
  • 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