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Carbon Dioxide Assay Kit (PEPC Enzymatic Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0101256Model CH0100256 CH0101256 CH0103256 CH0800256 CH0801256 CH0802256 CH0803256 CH0804256

EMDN W0101070108

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0802567A 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
CH0100256 CH0101256 CH0103256 CH0800256 CH0801256 CH0802256 CH0803256 CH0804256, CH0101256
Primary DI / UDI-DI
06950617450511
Basic UDI-DI
69506174CH0802567A
Direct Marketing DI
06950617450511
EMDN Code
W0101070108 Carbon dioxide (bicarbonate) - electrodes (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
  • 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 06950617450511|69506174CH0802567A 61 fields · synced 23 Oct 2026