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Corail Amt

by DePuy Ireland UC EUDAMED510(k)GUDID

Active United States and European Union

Ref L94007Model CORAIL AMT Hip Neck Femoral Trial Prosthesis510(k) K190344

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a000728F Basic UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK190344 Date1 Nov 2019ClearedStatusActive
United StatesGUDID listing GUDID Number10603295325185 UDI-DIDate24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Corail Amt EUDAMED
Corail GUDID
Generic Name
Femoral stem prosthesis trial
Device Name
Hip Neck Femoral Trial Prosthesis
Model / Ref / Catalog
CORAIL AMT Hip Neck Femoral Trial Prosthesis, L94007
Primary DI / UDI-DI
10603295325185
Basic UDI-DI
0603295a000728F
Direct Marketing DI
10603295325185
FDA Product Code
LXH
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Femoral stem prosthesis trial
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
Market of Registration
Ireland
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 IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IE-MF-000007377
FDA applicant
Depuy(Ireland)

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • CMR Substance
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Manufacturing Date: No