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Arthrex® ABS-10017

by Arthrex, Inc.

Ref ABS-10017Model ACP Max Counterbalance

Arthrex® ABS-10017 is a device classified as Class IIa in the EU and Class I in the US made by Arthrex, Inc., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI B-00888867334786) and listed in FDA GUDID since 16 Mar 2023 (UDI-DI 00888867334786), 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-00888867334786 Basic UDI-DI 00888867334786UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867334786 UDI-DI Date16 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00888867334786 registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 00888867334786 listed 16 Mar 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867334786
  2. Registered EUDAMED B-00888867334786

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  • Withdrawn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
Arthrex®
Generic name
Centrifuge tube counterbalance
Model / Ref / Catalog
ABS-10017, ACP Max Counterbalance
Primary DI / UDI-DI
00888867334786
Basic UDI-DI
B-00888867334786
FDA product code
JQO
EMDN code
B0501 Platelet gel automatic preparation devices (excluding bags)
GMDN term
Centrifuge tube counterbalance
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
862.2050
EU registration type
Legacy device (under a directive)
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.

Related devices

Category: Centrifuge tube counterbalance

Similar devices in this category

Other devices filed under PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS).

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)