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Alkaline Phosphatase Assay Reagent Kit (NPP-AMP Buffer Method)

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

Ref R02112Model R1：40ml×4，R2：20ml×2 EMDN W01010106

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R02112YW Basic UDI-DIDate21 Jul 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  • Withdrawn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
Alkaline Phosphatase Assay Reagent Kit (NPP-AMP Buffer Method)
Model / Reference
R1：40ml×4，R2：20ml×2, R02112
Primary DI / UDI-DI
D-R02112YW
Basic UDI-DI
B-R02112YW
EMDN Code
W01010106 Alkaline phosphatase isoenzymes (cc)
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 & 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 41ccf2c3-40fb-42a3-ac46-f921b4df72a0 61 fields · synced 24 Oct 2026