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Medline DYNDE20125

by Medline Industries, Inc.

Ref DYNDE20125

Medline DYNDE20125 is an irrigation syringe (EU MDR Class I; FDA Class I; FDA product code KYZ, Syringe, Irrigating (Non Dental)) made by Medline Industries, Inc., registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI 0884389DC228STJZ) and listed in FDA GUDID since 17 Aug 2021 (UDI-DI 00884389102315), active as of 23 Oct 2026.

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

CE MDR

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
European UnionCE/MDR EUDAMED Number0884389DC228STJZ Basic UDI-DI 00884389102315UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884389102315 UDI-DI Date17 Aug 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884389DC228STJZ registered 22 Jul 2026 Active
  • FDA GUDID UDI-DI 00884389102315 listed 17 Aug 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884389102315
  2. Registered EUDAMED 0884389DC228STJZ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Medline
Generic name
Irrigation syringe
Device name
Irrigation syringes
Model / Ref / Catalog
DYNDE20125
Primary DI / UDI-DI
00884389102315 EUDAMED
10884389102312 GUDID
Basic UDI-DI
0884389DC228STJZ
FDA product code
KYZ
EMDN code
A02010299 Infusion and irrigation syringes - other
GMDN term
Irrigation syringe
Device class
Class I
Regulation number
880.6960
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00884389102315
GUDID
10884389102312

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00884389102315; FDA GUDID lists 10884389102312), so their flags are not compared.

Related devices

Category: Irrigation syringe

Similar devices in this category

Other devices filed under INFUSION AND IRRIGATION SYRINGES - OTHER.

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)