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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

n/A — Class I MDR by Limedix GmbH

MD Atlas
Limedix GmbH

EUDAMED last updated this device on Apr 4, 2023

n/A

426073241aphasiaRG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Limedix GmbH
UDI-DI code: 04260732410034
Reference / catalog number: n/A

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Manufacturer information

Organization name: Limedix GmbH
SRN: DE-MF-000006340
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
https://neolexon.de/wp-content/uploads/2021/04/gebrauchsanweisung-neolexon-aphasie-app.pdf

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: 04260732410034
Basic UDI-DI: 426073241aphasiaRG
Reference / catalog number: n/A
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: neolexon Aphasie bietet eine digitale Sprachtherapie für Patienten mit Aphasie und/oder Sprechapraxie, die aufgrund einer neurologischen Erkrankung sprachliche Beeinträchtigungen haben. Die digitale Anwendung soll die logopädische Therapie zielgerichtet intensivieren und die sprachlichen Fähigkeiten verbessern. neolexon Aphasie ist nur anwendbar als Ergänzung zur Behandlung beim Logopäden/ Sprachtherapeuten. Die Anwendung ist nicht dafür bestimmt, Informationen für diagnostische oder therapeutische Entscheidungen zu liefern.
Additional information URL: https://neolexon.de/wp-content/uploads/2021/04/gebrauchsanweisung-neolexon-aphasie-app.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

neolexon Artikulationsstörung426073241articulation2TOn the market neolexon Therapeut426073241aphasiaRGOn 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.