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Dry immunoassay analyzer

by Guangzhou KOFA Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref 1FF00006Model Please see UDI-DI for detail

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697457620SSDiaXY Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Please see UDI-DI for detail, 1FF00006
Primary DI / UDI-DI
06974576207672
Basic UDI-DI
697457620SSDiaXY
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000045346
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Guangzhou KOFA Biotechnology Co., Ltd.

See all devices from Guangzhou KOFA Biotechnology Co., Ltd. →

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