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Biochemical and immunoassay analyzer

by Dezhou Guoke Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref GKPD084Model Semi-auto Chemistry Analyzer：CAS60,CAS70,CAS80,CAS90； Auto Chemistry Analyzer:Mini 60、CAS100、S120pro、CAS200、CAS300、CAS400

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697769840GKPD0846X Basic UDI-DIDate15 Jul 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  • Withdrawn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
Semi-auto Chemistry Analyzer：CAS60, CAS70, CAS80, CAS90； Auto Chemistry Analyzer:Mini 60、CAS100、S120pro、CAS200、CAS300、CAS400, GKPD084
Primary DI / UDI-DI
06977698404875
Basic UDI-DI
697769840GKPD0846X
Direct Marketing DI
06977698404875
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000044128
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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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