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HIP Instruments 01.18.10.410

by Medacta International SA

Ref 01.18.10.410

HIP Instruments 01.18.10.410 is a Class I device made by Medacta International SA, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-07630040745482) and listed in FDA GUDID since 9 Dec 2020 (UDI-DI 07630040745482), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630040745482 Basic UDI-DI 07630040745482UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040745482 UDI-DI Date9 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07630040745482 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 07630040745482 listed 9 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630040745482
  2. Registered EUDAMED B-07630040745482

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  • Withdrawn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
AMIStem Broach v2 #0 EUDAMED
HIP Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Hip Broach / Femoral Rasp / Puncher
Model / reference
01.18.10.410
Primary DI / UDI-DI
07630040745482
Basic UDI-DI
B-07630040745482
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
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

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

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)