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Haptoglobin Assay Kit (Immunoturbidimetric Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0802319Model CH0102319 CH0100319 CH0801319 CH0800319 CH0802319 CH0803319 CH0804319 CH0191319 CH0192319

EMDN W0102010302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH08031979 Basic UDI-DIDate16 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
CH0102319 CH0100319 CH0801319 CH0800319 CH0802319 CH0803319 CH0804319 CH0191319 CH0192319, CH0802319
Primary DI / UDI-DI
06950617446422
Basic UDI-DI
69506174CH08031979
Direct Marketing DI
06950617446422
EMDN Code
W0102010302 Haptoglobin
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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06950617446422|69506174CH08031979 61 fields · synced 24 Oct 2026