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Galactography Kit DGK002X

by Argon Medical Devices, Inc.

Ref DGK002X

Galactography Kit DGK002X is a device classified as Class I in the EU and Class II in the US made by Argon Medical Devices, Inc., registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI B-20886333001587) and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 20886333001587), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20886333001587 Basic UDI-DI 20886333001587UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20886333001587 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-20886333001587 registered 1 Jul 2026 Active
  • FDA GUDID UDI-DI 20886333001587 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 20886333001587
  2. Registered EUDAMED B-20886333001587

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Galactography EUDAMED
Galactography Kit GUDID
Generic name
Breast ductography cannula
Model / Ref / Catalog
DGK002X
Primary DI / UDI-DI
20886333001587 EUDAMED
00886333001583 GUDID
Basic UDI-DI
B-20886333001587
FDA product code
FMI
EMDN code
A019005 Galactography needles and kits
GMDN term
Breast ductography cannula
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.5570
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20886333001587
GUDID
00886333001583
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 20886333001587; FDA GUDID lists 00886333001583), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Breast ductography cannula

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Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)