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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_0098_2.0.0 — Class IIa MDR by Brainhero GmbH

MD Atlas
Brainhero GmbH

EUDAMED last updated this device on Jan 16, 2024

HP_0098_2.0.0

918000413ORBITHB016S

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Brainhero GmbH
UDI-DI code: 09180004130161
Reference / catalog number: HP_0098_2.0.0

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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	Jan 17, 2024	Still on market
Germany	Jan 17, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09180004130161
Basic UDI-DI: 918000413ORBITHB016S
Reference / catalog number: HP_0098_2.0.0
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N01010203EEG HEADSETS

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

HP_0104918000413OrbitNDOn the market BrainheroApp918000413NAMG01YJOn the market HP_0098918000413ORBITHB016SOn 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.