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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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Niviu System — 3 UDI-DI variants, MDR (Elixion Medical GmbH)

MD Atlas
Elixion Medical GmbH

Data from EUDAMED, last updated May 23, 2026

Niviu System

417000019368SC2168

3 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: Elixion Medical GmbH

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Device characteristics

Active deviceMeasuring function

Identity & classification

Basic UDI-DI: 417000019368SC2168
Device name: Niviu System
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jul 11, 2025

Manufacturer & authorised representative

Manufacturer

Name: Elixion Medical GmbH
SRN: DE-MF-000043056
Country: Germany
Email: info@elixionmedical.com

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01JZWVAK5Z96HDTFGFZEZ8X598

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

ELX-000104170000225829
ELX-000204170000225836
ELX-001004170000249634