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Urinary Total Protein Assay Kit (Pyrogallol Red-Molybdate Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0801063Model CH0101063 CH0102063 CH0105063 CH0106063 CH0800063 CH0801063 CH0802063 CH0803063 CH0804063

EMDN W01010230

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0800636V 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 23 Oct 2026

Model / Reference
CH0101063 CH0102063 CH0105063 CH0106063 CH0800063 CH0801063 CH0802063 CH0803063 CH0804063, CH0801063
Primary DI / UDI-DI
06950617448563
Basic UDI-DI
69506174CH0800636V
Direct Marketing DI
06950617448563
EMDN Code
W01010230 Total protein
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
  • 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 06950617448563|69506174CH0800636V 61 fields · synced 23 Oct 2026