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Reamer, Hip

by DePuy Ireland UC 9 variants

Ref 961183000Model DEPUY MI SYSTEM Reamer, Hip

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 Number0603295a004628Y Basic UDI-DI 10603295235408UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295235408 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  • Withdrawn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
C-Stem
Generic Name
Bone-resection orthopaedic reamer, reusable
Device Name
Reamer, Hip
Model / Ref / Catalog
DEPUY MI SYSTEM Reamer, Hip, 961183000, 9611-83-000
Primary DI / UDI-DI
10603295235408
Basic UDI-DI
0603295a004628Y
FDA Product Code
HTO
EMDN Code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN Term
Bone-resection orthopaedic reamer, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DEPUY MI SYSTEM Reamer, Hip
961183000
GUDID
9611-83-000
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Related devices

Category: Acetabular orthopaedic reamer

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