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Glucose Assay Reagent Kit (Hexokinase Method)

by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED

Ref R05711Model R1:50mL×4 R2:25mL×2；1mL×1 EMDN W01010213

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R057112J Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Glucose Assay Reagent Kit (Hexokinase Method)
Model / Reference
R1:50mL×4 R2:25mL×2；1mL×1, R05711
Primary DI / UDI-DI
D-R057112J
Basic UDI-DI
B-R057112J
EMDN Code
W01010213 Glucose
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Rayto Life and Analytical Sciences Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED D-R057112J|B-R057112J 61 fields · synced 24 Oct 2026