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Anti-Streptolysin O Assay Kit (Latex Immunoturbidimetric Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0805019Model CH0100019 CH0101019 CH0802019 CH0801019 CH0800019 CH0803019 CH0804019 CH0805019

EMDN W01021104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0800196S 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 24 Oct 2026

Model / Reference
CH0100019 CH0101019 CH0802019 CH0801019 CH0800019 CH0803019 CH0804019 CH0805019, CH0805019
Primary DI / UDI-DI
06950617468158
Basic UDI-DI
69506174CH0800196S
Direct Marketing DI
06950617468158
EMDN Code
W01021104 Anti-streptolysin o (quantitative)
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 06950617468158|69506174CH0800196S 61 fields · synced 24 Oct 2026