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Urinary Microalbumin Assay Kit (Immunoturbidimetric Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0804060Model CH0106060 CH0101060 CH0801060 CH0800060 CH0802060 CH0803060 CH0804060

EMDN W01010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0800606P Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
CH0106060 CH0101060 CH0801060 CH0800060 CH0802060 CH0803060 CH0804060, CH0804060
Primary DI / UDI-DI
06950617466581
Basic UDI-DI
69506174CH0800606P
Direct Marketing DI
06950617466581
EMDN Code
W01010201 Albumin (cc)
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

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06950617466581|69506174CH0800606P 61 fields · synced 23 Oct 2026