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Reagent for Electrolyte Analyzer（Standard Solution B）

by Dezhou Guoke Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref GKPD076BModel 430ml/bag、70ml/bottle （bag）、350ml/bottle （bag）、110ml/bottle （bag）

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977698404264 Basic UDI-DIDate3 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
430ml/bag、70ml/bottle （bag）、350ml/bottle （bag）、110ml/bottle （bag）, GKPD076B
Primary DI / UDI-DI
06977698404264
Basic UDI-DI
B-06977698404264
EMDN Code
W0101050301 Calibrators multicomponent (cc)
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

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

Other devices from Dezhou Guoke Medical Technology Co., Ltd.

See all devices from Dezhou Guoke Medical Technology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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