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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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Orbit Headband — 2 UDI-DI variants, MDR (Brainhero GmbH)

MD Atlas
Brainhero GmbH

Data from EUDAMED, last updated May 23, 2026

Orbit Headband

918000413ORBITHB016S

2 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: Brainhero GmbH

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 918000413ORBITHB016S
Device name: Orbit Headband
Device model: Headband
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jan 16, 2024

Manufacturer & authorised representative

Manufacturer

Name: Brainhero GmbH
SRN: AT-MF-000022440
Country: Austria
Email: help@brainhero.eu
Phone: +43 19974294

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01HM8ZS8ENMW63J6D55CV7GGR1

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

HP_0098_2.0.009180004130161
HP_009809180004130086