S-Rom Noiles

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Knee femur prosthesis trial, reusable

Model / Ref / Catalog

63-4151R, 634151R

Primary DI / UDI-DI

10603295181576

Basic UDI-DI

0603295a0020386

Direct Marketing DI

10603295181576

FDA Product Code

HWT

EMDN Code

L091199 Orthopaedic prosthetics instruments, reusable - other

GMDN Term

Knee femur prosthesis trial, reusable

Device Class

Class IIa EUDAMED

Class I GUDID

Regulation Number

888.4800

Market of Registration

Ireland

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

EUDAMED SRN

IE-MF-000007377

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  Class III

  CE/MDR MDR 755208 Active Valid to Jul 2029

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  CE/MDR MDR 781841 Active Valid to Jul 2030

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  CE/MDR

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  CE/MDR

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  CE/MDR MDR 755208 Active Valid to Jul 2029

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