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U2 Hip Stem 9104-8110-RA

by United Orthopedic Corp.

Ref 9104-8110-RA

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04719872146056 UDI-DI Date11 Sep 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number471987216TD-Ir-003F4 Basic UDI-DI 04719872146056UDI-DIDate18 Feb 2025RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
U2 Hip Stem
Generic Name
Instrument tray, reusable
Device Name
United Hip and Knee Non-sterile Reusable Instruments
Model / Ref / Catalog
9104-8110-RA
Primary DI / UDI-DI
04719872146056
Basic UDI-DI
471987216TD-Ir-003F4
Direct Marketing DI
04719872146056
510(k) Number
FDA Product Code
LPH, MEH
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Instrument tray, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3358, 888.3353
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K003237)

Show all (12)

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Expiration Date: No