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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Tibial Keel trial — 6 UDI-DI variants, MDR (DePuy Ireland UC)

MD Atlas
DePuy Ireland UC

Data from EUDAMED, last updated May 24, 2026

Tibial Keel trial

0603295a001718J

6 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: DePuy Ireland UC

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 0603295a001718J
Device name: Tibial Keel trial
Device model: SIGMA HP Tibial Keel Trial
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Dec 30, 2025

Manufacturer & authorised representative

Manufacturer

Name: DePuy Ireland UC
SRN: IE-MF-000007377
Country: Ireland
Email: EUDAMED_Enquiries@its.jnj.com
Phone: +353 (0)214914000

Variants by status

UDI-DI variants

6 UDI-DI variants

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Applied filters

basicUdiUlid01KDQSYNVV4XZVBENNZEC2BX2Z

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

SIGMA HP10603295083085
SIGMA HP10603295083214
SIGMA HP10603295083184
SIGMA HP10603295083092
SIGMA HP10603295083078
SIGMA HP10603295083207