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Aso

by Medicon Hellas SA 2 variants

Ref 1418-1065

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05204309104352 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number5204309000008NS Basic UDI-DI 05204309104352UDI-DIDate13 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
1418-1065
Primary DI / UDI-DI
05204309104352
Basic UDI-DI
5204309000008NS
EMDN Code
W01021104 Anti-streptolysin o (quantitative)
GMDN Term
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Device Class
Class B
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
GR-MF-000013625

Other devices from Medicon Hellas SA

See all devices from Medicon Hellas SA →

Properties

  • Reagent
  • Professional Testing
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No