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Fluorescent Immunoanalyzer

by Sino-Swed TongKang Bio-Tech (Shenzhen) Limited. EUDAMED

Active European Union

Ref /Model DFI-1000

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697069856DFI1000P7 Basic UDI-DIDate20 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
DFI-1000, /
Primary DI / UDI-DI
06970698560251
Basic UDI-DI
697069856DFI1000P7
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class A
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000033668
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Sino-Swed TongKang Bio-Tech (Shenzhen) Limited.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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