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Organization name
UDI-DI code
Reference / catalog number

Cogthera App 1.x.x — Class I MDR by Cogthera GmbH

MD Atlas
Cogthera GmbH

EUDAMED last updated this device on May 13, 2026

Cogthera App 1.x.x

426245535COGTHERA2023F2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cogthera GmbH
UDI-DI code: 04262455350000
Reference / catalog number: Cogthera App 1.x.x

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Manufacturer information

Organization name: Cogthera GmbH
SRN: DE-MF-000038894
Manufacturer status: Active

Critical warnings

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

CW999
Ausschlusskriterien sind die Nicht-Verfügbarkeit eines internetfähigen mobilen Endgerätes, vollständige Immobilität oder das Fehlen von ausreichenden deutschen Sprachkenntnissen. Weitere Ausschlusskriterien sind eine schwere Demenz oder andere Formen von Demenz nach ICD-10 (F00.–, F01.–, F02.– und F03). Zusätzliche Ausschlusskriterien: Kognitive oder physische Einschränkungen, die das Verständnis von Anweisungen und Übungen in der Anwendung fehlerhaft machen. Beeinträchtigung der sensorischen Wahrnehmung aufgrund von Medikamenten, Verletzungen oder Krankheiten.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262455350000
Basic UDI-DI: 426245535COGTHERA2023F2
Reference / catalog number: Cogthera App 1.x.x
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: Cogthera is a mobile application that provides a multimodal intervention for adult patients with mild cognitive impairment or mild dementia. The patient-centered application is intended to promote cognitive functions. The intervention includes individualized cognitive training, movements as part of dual-tasks, audio-guided meditations, and educational content.
Additional information URL: https://www.cogthera.de/
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

This device is not currently linked to any other device.

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.