Skip to content

Sigma Hp

by DePuy Ireland UC 51 variants

Ref 2024-56-111, 2011-03-057, 2024-11-608, 2024-08-500, 2011-03-049, 2024-85-001, 2024-65-000, 2024-47-111, 2011-03-080, 2024-44-111, 2024-11-510, 2011-03-006Model TruMatch Instrument Case/Tray

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 Number0603295a005128N Basic UDI-DI Date23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295083313 UDI-DI Date24 Sep 2018ListedStatusListed 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  • Withdrawn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
Sigma Hp EUDAMED
Sigma GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Surgical screwdriver, reusable
Knee tibia prosthesis trial, reusable
Knee femur prosthesis trial, reusable
Orthopaedic osteotome
Device sterilization/disinfection container, reusable
Instrument tray, reusable
Device Name
Positioning/ Alignment Instrument
Partial Knee Femoral Trial
Instrument Case/Tray
Shim
Sterilization Tray
Orthopaedic Chisel/Osteotome
Cutting Guide
Model / Ref / Catalog
2024-56-111, 2011-03-057, 2011-03-006, 2011-03-080, 2024-11-608, 2024-85-001, 2024-47-111, 2024-08-500, 2024-65-000, 2024-11-510, 2024-44-111, 2011-03-049, TruMatch Instrument Case/Tray, 201103057, 201103006, 201103080, 202411608, 202485001, 202447111, 202408500, 202465000, 202456111, 202411510, 202444111, 201103049
Primary DI / UDI-DI
10603295083313, 10603295327189, 10603295081272, 10603295436379, 10603295082934, 10603295084037, 10603295083191, 10603295082651, 10603295083535, 10603295082903, 10603295083115, 10603295081685
Basic UDI-DI
0603295a005128N, 0603295a0003487, 0603295a001708G, 0603295a001698X, 0603295a000107R, 0603295a002448L, 0603295a0004184, 0603295a002328D, 0603295a0004082, 0603295a002248E
Direct Marketing DI
10603295083313
10603295327189
10603295082934
10603295082651
10603295081685
10603295084037
10603295083535
10603295083191
10603295436379
10603295083115
10603295082903
10603295081272
FDA Product Code
HWT, HXX, HWM, FSM
EMDN Code
L091199, L0999, L090401, L26, L0922
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Surgical screwdriver, reusable
Knee tibia prosthesis trial, reusable
Knee femur prosthesis trial, reusable
Orthopaedic osteotome
Device sterilization/disinfection container, reusable
Instrument tray, reusable
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Regulation Number
888.4800, 888.4540, 878.4800
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 I
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • Reusable YesEUDAMEDNoEUDAMED
  • 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