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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

neolexon Artikulationsstörung — Class I MDR by Limedix GmbH

MD Atlas
Limedix GmbH

EUDAMED last updated this device on Apr 4, 2023

neolexon Artikulationsstörung

426073241articulation2T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Limedix GmbH
UDI-DI code: 04260732410003
Reference / catalog number: neolexon Artikulationsstörung

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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-artikulationsstoerungen.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: 04260732410003
Basic UDI-DI: 426073241articulation2T
Reference / catalog number: neolexon Artikulationsstörung
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 bei Artikulationsstörungen ist eine App zum Eigentraining für Kinder mit Störungen der Aussprache mit motivierenden Elementen, die ergänzend zur Therapie beim Logopäden/Sprachtherapeuten zum Einsatz kommt und damit die logopädische Therapie zielgerichtet intensivieren soll.
Additional information URL: https://neolexon.de/wp-content/uploads/2021/04/gebrauchsanweisung-neolexon-artikulationsstoerungen.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

n/A426073241aphasiaRGOn 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.