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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

HP_0104 — Class IIa MDR by Brainhero GmbH

MD Atlas
Brainhero GmbH

EUDAMED last updated this device on Oct 17, 2023

HP_0104

918000413OrbitND

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Brainhero GmbH
UDI-DI code: 09180004130079
Reference / catalog number: HP_0104

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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: 09180004130079
Basic UDI-DI: 918000413OrbitND
Reference / catalog number: HP_0104
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: The Orbit is a mobile EEG device. It is used to measure electrical activity and the movement of the head. It can be used to measure up to 4 electrodes and send them via Bluetooth low energy to a tablet where the signal can be used to perform neurofeedback. In this case, the whole EEG is placed on the head of the user (a headband is required to do so).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12100801EEG TELEMETRY SYSTEMS

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

Related devices

BrainheroApp918000413NAMG01YJOn the market HP_0098918000413ORBITHB016SOn the market HP_0098_2.0.0918000413ORBITHB016SOn the market

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.