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Arthrex® 5566VIP

by Arthrex, Inc.

Ref 5566VIP

Arthrex 5566VIP is a medical device (EU MDR Class I; FDA Class II; FDA product code QHE, Shoulder arthroplasty implantation system; EMDN category various instruments for general and multidisciplinary surgery) made by Arthrex, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 0888867VIPWebPort000000DX) and listed in FDA GUDID since 3 Sep 2024 (UDI-DI 00888867264953), 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 Number0888867VIPWebPort000000DX Basic UDI-DI 00888867264953UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867264953 UDI-DI Date3 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888867VIPWebPort000000DX registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00888867264953 listed 3 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867264953
  2. Registered EUDAMED 0888867VIPWebPort000000DX

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  • Withdrawn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 EUDAMED
Arthrex® GUDID
Generic name
Orthopaedic/craniofacial implantation planning software
Device name
Virtual Implant Positioning (VIP)
Model / Ref / Catalog
5566VIP
Primary DI / UDI-DI
00888867264953
Basic UDI-DI
0888867VIPWebPort000000DX
FDA product code
QHE
EMDN code
Z12019099 Various instruments for general and multidisciplinary surgery - other
GMDN term
Orthopaedic/craniofacial implantation planning software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660
Special device type
Software
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Orthopaedic/craniofacial implantation planning software

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Reusable
  • Prescription use
Other properties (23, all answered No)