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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

My7steps App - Digitale… — Class I MDR by My7steps GmbH

MD Atlas
My7steps GmbH

EUDAMED last updated this device on Mar 20, 2026

My7steps App - Digitale Gesundheitsanwendung (DiGA)

426250239M7SA01WX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: My7steps GmbH
UDI-DI code: 04262502390461
Reference / catalog number: My7steps App - Digitale Gesundheitsanwendung (DiGA)

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Manufacturer information

Organization name: My7steps GmbH
SRN: DE-MF-000014074
Manufacturer status: Active

Critical warnings

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

CW999
My7steps App darf nicht genutzt werden, wenn der Nutzer: - in den letzten vier Wochen einen Selbstmord geplant oder versucht hat, - eine psychotische Störung (ICD-10 F20, F22, F23, F24) oder - eine schwere Depression (ICD-10 F32.2) diagnostiziert wurde.

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: 04262502390461
Basic UDI-DI: 426250239M7SA01WX
Reference / catalog number: My7steps App - Digitale Gesundheitsanwendung (DiGA)
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: Das Medizinprodukt My7steps App ist eine internet- und mobilbasierte Intervention (IMI) mittels Selbsthilfe zur Behandlung oder Linderung von depressiven Symptomen auf der Grundlage von Prinzipien der internetbasierten kognitiven Verhaltenstherapie (iCBT) und anderen evidenzbasierten psychotherapeutischen Konzepten.
Additional information URL: https://diga.my7steps.org/
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

My7steps App - Basisversion426250239M7SA01WXOn 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.