Skip to content

AMIStem Distal Broach - size 7D

by Medacta International SA

Ref 01.18.10.327

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274HSR0371N009W Basic UDI-DI 07630542788857UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630542788857 UDI-DI Date29 May 2026ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
AMIStem Distal Broach - size 7D EUDAMED
Surgical Manual Instrument GUDID
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Name
Hip Broach / Femoral Rasp / Puncher
Model / Reference
01.18.10.327
Primary DI / UDI-DI
07630542788857
Basic UDI-DI
764014274HSR0371N009W
Direct Marketing DI
07630542788857
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 market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
CH-MF-000033473
Authorised representative
Medacta Italia srl IT-AR-000022505

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

  • Reusable
  • CMR Substance
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No