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α-Hydroxybutyrate Dehydrogenase Assay Reagent Kit (α-Oxobutyric Method)

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

Active European Union

Ref R02517Model R1: 40ml×4, R2: 18ml×2

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R02517ZU Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

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

Specification

EUDAMED

Device Name
α-Hydroxybutyrate Dehydrogenase Assay Reagent Kit (α-Oxobutyric Method)
Model / Reference
R1: 40ml×4, R2: 18ml×2, R02517
Primary DI / UDI-DI
D-R02517ZU
Basic UDI-DI
B-R02517ZU
EMDN Code
W01010118 Hydroxybutyrate dehydrogenase
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

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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