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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 Infrapatellar Insertion Handle — 2 UDI-DI variants, MDR

MD Atlas
OrthoXel DAC

Data from EUDAMED, last updated May 24, 2026

Tibial Infrapatellar Insertion Handle

53915295840616F

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: OrthoXel DAC

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Device characteristics

Reusable

Identity & classification

Basic UDI-DI: 53915295840616F
Device name: Tibial Infrapatellar Insertion Handle
Device model: INS-1109
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Feb 12, 2025

Manufacturer & authorised representative

Manufacturer

Name: OrthoXel DAC
SRN: IE-MF-000000574
Country: Ireland
Email: regulatory@orthoxel.com
Phone: +353(0)212429700

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01JKXGT0JYH8N9F6QFFSD6BAG9

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

Suprapatellar Protection Sleeve Handle05391529584146
Tibial Infrapatellar Insertion Handle05391529584061