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Arthrex® AR-6420

by Arthrex, Inc.

Ref AR-6420

Arthrex® AR-6420 is a device classified as Class IIa in the EU and Class II in the US made by Arthrex, Inc., registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 0888867InflowTubePump00YU) and listed in FDA GUDID since 1 Sep 2025 (UDI-DI 00888867039155), 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 Number0888867InflowTubePump00YU Basic UDI-DI 00888867039155UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867039155 UDI-DI Date1 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888867InflowTubePump00YU registered 4 Aug 2026 Active
  • FDA GUDID UDI-DI 00888867039155 listed 1 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867039155
  2. Registered EUDAMED 0888867InflowTubePump00YU

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  • Withdrawn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
Arthrex®
Generic name
Arthroscopic surgical procedure kit, non-medicated, single-use
Device name
Inflow pump tubing
Model / Ref / Catalog
AR-6420
Primary DI / UDI-DI
00888867039155
Basic UDI-DI
0888867InflowTubePump00YU
FDA product code
HRX
EMDN code
A03040299 Irrigation kits, single-use - other
GMDN term
Arthroscopic surgical procedure kit, non-medicated, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.1100
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
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Arthroscopic surgical procedure kit, non-medicated, single-use

Similar devices in this category

Other devices filed under IRRIGATION KITS, SINGLE-USE - OTHER.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)