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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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Orthoses — 4 UDI-DI variants, MDR (Elitex Prodexim SRL)

MD Atlas
Elitex Prodexim SRL

Data from EUDAMED, last updated May 30, 2026

Orthoses

594476026ELTS00000001WP

4 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: Elitex Prodexim SRL

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 594476026ELTS00000001WP
Device name: Orthoses
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Feb 15, 2023

Manufacturer & authorised representative

Manufacturer

Name: Elitex Prodexim SRL
SRN: RO-MF-000033014
Country: Romania
Email: office@elitex.ro
Phone: +40744694393

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01GSB4K962C2J0QHZ5RTHXG0RY

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

Free-moving orthotic knee joint05944760260203
Orthotic knee joint with lock05944760260210
Orthotic knee joint with lock for children05944760260388
Polycentric knee joint with gear drive05944760260227