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

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0803203Model CH0101203 CH0105203 CH0800203 CH0801203 CH0802203 CH0803203 CH0804203

EMDN W01010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0802036M Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CH0101203 CH0105203 CH0800203 CH0801203 CH0802203 CH0803203 CH0804203, CH0803203
Primary DI / UDI-DI
06950617448396
Basic UDI-DI
69506174CH0802036M
Direct Marketing DI
06950617448396
EMDN Code
W01010105 Alkaline phosphatase - total
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06950617448396|69506174CH0802036M 61 fields · synced 24 Oct 2026