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β-Hydroxybutyrate (β-HB) Kit (Enzymatic Colorimetric Method)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. EUDAMED

Active European Union

Ref 105-004513-00Model 105-006184-00、105-004513-00、105-004514-00、105-002319-00、105-002320-00

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040004JB-HB*******Q2 Basic UDI-DIDate20 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
β-Hydroxybutyrate Kit (Enzymatic Colorimetric Method)、β-HB Calibrator、β-HB Control
Model / Reference
105-006184-00、105-004513-00、105-004514-00、105-002319-00、105-002320-00, 105-004513-00
Primary DI / UDI-DI
06944904053400
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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