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U2™ Hip 9104-3524

by United Orthopedic Corp.

Ref 9104-3524

U2™ Hip 9104-3524 is a device classified as Class IIa in the EU and Class I in the US made by United Orthopedic Corp., registered in EUDAMED on 11 Feb 2026 (Basic UDI-DI B-04719872172147) and listed in FDA GUDID since 22 Jun 2017 (UDI-DI 04719872172147), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719872172147 Basic UDI-DI 04719872172147UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872172147 UDI-DI Date22 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04719872172147 registered 11 Feb 2026 Active
  • FDA GUDID UDI-DI 04719872172147 listed 22 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04719872172147
  2. Registered EUDAMED B-04719872172147

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  • Withdrawn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
U2 Hip Stem EUDAMED
U2™ Hip GUDID
Generic name
Medullary canal orthopaedic reamer, flexible
Model / Ref / Catalog
9104-3524
Primary DI / UDI-DI
04719872172147
Basic UDI-DI
B-04719872172147
FDA product code
HTO
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Medullary canal orthopaedic reamer, flexible
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Medullary canal orthopaedic reamer, flexible

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE.

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)