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Aso

by Medicon Hellas SA 2 variants

Ref 1419-1066

Aso (1419-1066) is an in vitro diagnostic device (EU IVDR Class B; EMDN category anti-streptolysin o (quantitative)) made by Medicon Hellas SA, registered in EUDAMED on 13 Jun 2023 (Basic UDI-DI 5204309000008NS) and listed in FDA GUDID since 27 Apr 2026 (UDI-DI 05204309133901), active as of 22 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05204309133901 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number5204309000008NS Basic UDI-DI 05204309133901UDI-DIDate13 Jun 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5204309000008NS registered 13 Jun 2023 Active
  • FDA GUDID UDI-DI 05204309133901 listed 27 Apr 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 5204309000008NS
  2. Listed FDA GUDID 05204309133901

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  • Withdrawn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
1419-1066
Primary DI / UDI-DI
05204309133901
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 registration type
Standard device
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
GR-MF-000013625

Similar devices in this category

Other devices filed under ANTI-STREPTOLYSIN O (QUANTITATIVE).

Other devices from Medicon Hellas SA

See all devices from Medicon Hellas SA →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)