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Hip Instruments 01.23.10.0100

by Medacta International

Ref 01.23.10.0100

Hip Instruments 01.23.10.0100 is a Class I device made by Medacta International, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 764014274HSR0421N008L) and listed in FDA GUDID since 6 May 2024 (UDI-DI 07630345785725), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274HSR0421N008L Basic UDI-DI 07630345785725UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630345785725 UDI-DI Date6 May 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764014274HSR0421N008L registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 07630345785725 listed 6 May 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630345785725
  2. Registered EUDAMED 764014274HSR0421N008L

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  • Withdrawn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
Mbrace cable – Tensioner Body EUDAMED
Hip Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Hip Cerclage tensioner
Model / reference
01.23.10.0100
Primary DI / UDI-DI
07630345785725
Basic UDI-DI
764014274HSR0421N008L
Direct marketing DI
07630345785725
FDA product code
LXH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)