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Arthrex® AR-6435

by Arthrex, Inc.

Ref AR-6435

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888867OutflowPatSet000LT Basic UDI-DI 00888867118089UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867118089 UDI-DI Date15 Feb 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Patient outflow tubing
Model / Ref / Catalog
AR-6435
Primary DI / UDI-DI
00888867118089
Basic UDI-DI
0888867OutflowPatSet000LT
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 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

Related devices

Category: Arthroscopic surgical procedure kit, non-medicated, single-use

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No