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Organization name
UDI-DI code
Reference / catalog number

407001 — Class I MDR by Humanelektronik GmbH

MD Atlas
Humanelektronik GmbH

EUDAMED last updated this device on Dec 5, 2023

407001

426076432HEKOMMUNBASICXEZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Humanelektronik GmbH
UDI-DI code: 04260764320226
Reference / catalog number: 407001

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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 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04260764320226
Basic UDI-DI: 426076432HEKOMMUNBASICXEZ
Reference / catalog number: 407001
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 unterstützen Kommunikation mit Touchscreen
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214209ALPHABETIC AND SYMBOLIC COMMUNICATORS

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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Manufacturing date
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Software identification