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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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Organization name
UDI-DI code
Reference / catalog number

BrainheroApp — Class IIa MDR by Brainhero GmbH

MD Atlas
Brainhero GmbH

EUDAMED last updated this device on Oct 17, 2023

BrainheroApp

918000413NAMG01YJ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Brainhero GmbH
UDI-DI code: 09180004130147
Reference / catalog number: BrainheroApp

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Manufacturer information

Organization name: Brainhero GmbH
SRN: AT-MF-000022440
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Oct 3, 2022	Still on market
Germany	Oct 3, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09180004130147
Basic UDI-DI: 918000413NAMG01YJ
Reference / catalog number: BrainheroApp
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Brainhero app, is used for home-based neurofeedback training. The home-based neurofeedback training is aiming to alleviate and/or treat symptoms of ASD and ADHD in children ages 6-18 years. The training app (Brainhero) is designed to be used for 10-30 hours (cumulative) over multiple weeks.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062492BIOFEEDBACK INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.