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DG Reader Net 210700

by Diagnostic Grifols SA

DG Reader Net 210700 is a Class II device made by Diagnostic Grifols SA, registered in EUDAMED and listed in FDA GUDID since 27 Nov 2019 (UDI-DI 08437014205619), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08437014205619 UDI-DI Date27 Nov 2019ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 08437014205619 listed 27 Nov 2019 Listed

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  • Withdrawn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

Trade name
DG Reader Net
Generic name
Agglutination assay digital imaging reader/analyser IVD
Model / Ref / Catalog
210700
Primary DI / UDI-DI
08437014205619
FDA product code
KSZ
GMDN term
Agglutination assay digital imaging reader/analyser IVD
Device class
Class II
Regulation number
864.9175
GUDID distribution status
In Commercial Distribution

Related devices

Category: Agglutination assay digital imaging reader/analyser IVD

Similar devices

Other devices filed under FDA product code KSZ (System, Test, Automated Blood Grouping And Antibody).

Other devices from Diagnostic Grifols SA

See all devices from Diagnostic Grifols SA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)