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S-Rom Noiles

by DePuy Ireland UC EUDAMEDGUDID

Active European Union

Ref 62-3805Model SROM NRH Augments

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a004458Y Basic UDI-DIDate4 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295179542 UDI-DIDate24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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 25 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Knee arthroplasty wedge
Device Name
Augments
Model / Ref / Catalog
SROM NRH Augments, 62-3805, 623805
Primary DI / UDI-DI
10603295179542
Basic UDI-DI
0603295a004458Y
510(k) Number
FDA Product Code
JWH
EMDN Code
P09098001 Knee prostheses augments
GMDN Term
Knee arthroplasty wedge
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3560
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No