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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

2159 — Class I MDR by Humanelektronik GmbH

MD Atlas
Humanelektronik GmbH

EUDAMED last updated this device on Oct 9, 2024

2159

426076432HEPROEye47

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Humanelektronik GmbH
UDI-DI code: 04260764320370
Reference / catalog number: 2159

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Manufacturer information

Organization name: Humanelektronik GmbH
SRN: DE-MF-000013990
Manufacturer status: Active

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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.

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260764320370
Basic UDI-DI: 426076432HEPROEye47
Reference / catalog number: 2159
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Hilfsmittel zur unterstützten Kommunikation mit Augensteuerung
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214299DEVICES FOR INTERPERSONAL COMUNICATION - OTHER

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

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