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C-Stem Amt

by DePuy Ireland UC 11 variants

Ref 2580-04-086, 2570-04-150, 2580-05-087, 2580-02-085, 2570-04-250, 2580-01-023, 2580-03-086, 2598-07-532, 2580-04-087, 2570-04-105, 2580-01-013, 2580-03-087, 2580-00-122, 2570-04-350, 2580-01-086, 2570-04-205, 2570-04-000, 2580-00-118Model C-STEM AMT Femoral Stem Trial Prosthesis, Hip, C-STEM AMT Neck Femoral Stem Trial Prosthesis, C-STEM AMT Hip Femoral Broach Instrument

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a000718D Basic UDI-DI Date23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295478348 UDI-DI Date22 Sep 2022ListedStatusListed 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  • Withdrawn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
C-Stem Amt EUDAMED
C-Stem EUDAMEDGUDID
Generic Name
Orthopaedic broach
Device Name
Femoral Stem Trial Prosthesis, Hip
Neck Femoral Stem Trial Prosthesis
Bone Osteotome, Hip
Hip Femoral Broach Instrument
Model / Ref / Catalog
C-STEM AMT Femoral Stem Trial Prosthesis, Hip, 2580-04-086, C-STEM AMT Neck Femoral Stem Trial Prosthesis, 2570-04-150, 2580-05-087, 2580-02-085, 2570-04-250, 2580-01-023, 2580-03-086, 2598-07-532, 2580-04-087, 2570-04-105, 2580-01-013, 2580-03-087, C-STEM AMT Hip Femoral Broach Instrument, 2580-00-122, 2570-04-350, 2580-01-086, 2570-04-205, 2580-00-118, 2570-04-000, 258000118, 258000122
Description
C-STEM AMT BROACH SIZE 4
C-STEM AMT BROACH SIZE 8
Primary DI / UDI-DI
10603295478348, 10603295490463, 10603295478386, 10603295478263, 10603295490487, 10603295478126, 10603295478355, 10603295490661, 10603295478362, 10603295490456, 10603295478249, 10603295478379, 10603295490647, 10603295490500, 10603295478164, 10603295490470, 10603295490609, 10603295490432
Basic UDI-DI
0603295a000718D, 0603295a0005085, 0603295a004679A, 0603295a0005187
Direct Marketing DI
10603295490647
10603295490609
FDA Product Code
QBO
EMDN Code
L091199, L090401, L091201
GMDN Term
Orthopaedic broach
Device Class
Class IIa EUDAMED
Class I EUDAMED
Class II GUDID
Regulation Number
888.4505
EU 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
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • Reusable NoEUDAMEDYesEUDAMED
  • CMR Substance NoEUDAMEDYesEUDAMED
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • 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
  • Manufacturing Date: No