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Antistreptolysin O Titre (ASOT)

by Egyptian Company For Biotechnology-Spectrum Diagnostics Egypt EUDAMED

Ref 510 002, 510 003, 510 001 EMDN W01021105

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-62230041006048 Basic UDI-DIDate18 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
510 002, 510 003, 510 001
Primary DI / UDI-DI
62230041006048, 62230041006116, 62230041005980
Basic UDI-DI
B-62230041006048, B-62230041006116, B-62230041005980
EMDN Code
W01021105 Anti-streptolysin o reaction time / titre (qualitative)
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
EG-MF-000032599
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Egyptian Company For Biotechnology-Spectrum Diagnostics

See all devices from Egyptian Company For Biotechnology-Spectrum Diagnostics →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (3)

  • EUDAMED 5106c055-40ae-460d-9692-217628f7f084 61 fields · synced 22 Oct 2026
  • EUDAMED 62230041006116|B-62230041006116 61 fields · synced 17 May 2026
  • EUDAMED 62230041005980|B-62230041005980 61 fields · synced 17 May 2026