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Arthrex® AR-3210-0064

by Arthrex, Inc.

Ref AR-3210-0064

Arthrex® AR-3210-0064 is a device classified as Class IIa in the EU and Class I in the US made by Arthrex, Inc., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 0888867NanoNdlKitShe0006F) and listed in FDA GUDID since 28 Jan 2026 (UDI-DI 00888867516144), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888867NanoNdlKitShe0006F Basic UDI-DI 00888867516144UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867516144 UDI-DI Date28 Jan 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888867NanoNdlKitShe0006F registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00888867516144 listed 28 Jan 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867516144
  2. Registered EUDAMED 0888867NanoNdlKitShe0006F

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  • Withdrawn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
NanoNeedle Scope - Sheath
Model / Ref / Catalog
AR-3210-0064
Primary DI / UDI-DI
00888867516144
Basic UDI-DI
0888867NanoNdlKitShe0006F
FDA product code
NBH
EMDN code
K030212 Arthroscopy instrument kits, single use
GMDN term
Arthroscopic surgical procedure kit, non-medicated, single-use
Device class
Class IIa EUDAMED
Class I 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 I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ARTHROSCOPY INSTRUMENT KITS, SINGLE USE.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)