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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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Brainlab Elements Image Fusion — 3 UDI-DI variants, MDR (Brainlab SE)

MD Atlas
Brainlab SE

Data from EUDAMED, last updated May 23, 2026

Brainlab Elements Image Fusion

4056481FusionP4

3 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: Brainlab SE

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 4056481FusionP4
Device name: Brainlab Elements Image Fusion
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Special device type: refdata.special-mdr-device-type.software
Version date: Jun 30, 2025

Manufacturer & authorised representative

Manufacturer

Name: Brainlab SE
SRN: DE-MF-000006183
Country: Germany
Email: regulatory.affairs@brainlab.com

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01JYZXH4V2QTZQEX8TNYX33HPM

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

Brainlab Elements Image Fusion, 4.004056481140816
Brainlab Elements Image Fusion, 4.504056481143992
Brainlab Elements Image Fusion, 5.004056481145873