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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

Orthopy App — Class I MDR by Orthopy Health GmbH

MD Atlas
Orthopy Health GmbH

EUDAMED last updated this device on Aug 29, 2025

Orthopy App

426242559OrthopyApp01PH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthopy Health GmbH
UDI-DI code: 04262425590009
Reference / catalog number: Orthopy App

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Manufacturer information

Organization name: Orthopy Health GmbH
SRN: DE-MF-000036442
Manufacturer status: Active

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.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW030
Sollten Sie noch keine Diagnose von Ihrer Ärztin oder Ihrem Arzt erhalten haben, holen Sie dies bitte vor der Nutzung von Orthopy nach. Diese Maßnahme dient vor allem dem Ausschluss der Möglichkeit, dass Ihre Beschwerden auf bestimmte Ursachen zurückzuführen sind, die eine spezielle Therapie erfordern würden. Außerdem sollten Sie im Rahmen Ihres Arztbesuchs abklären lassen, dass keine Gegenanzeigen für die Anwendung von Orthopy bestehen.
CW010
Lesen Sie diese Anweisungen sorgfältig durch, bevor Sie die Applikation benutzten. Dieses Dokument enthält wichtige Informationen und Anweisungen über die korrekte und sichere Verwendung der Applikation.p sorgfältig durch.
CW999
Mit Orthopy kann keine Diagnose Ihrer Krankheit gestellt werden. Die App liefert keine Informationen, die dazu bestimmt sind, Entscheidungen für diagnostische oder therapeutische Zwecke zu treffen.

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: 04262425590009
Basic UDI-DI: 426242559OrthopyApp01PH
Reference / catalog number: Orthopy App
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: Orthopy is a digital therapy app providing exercise programs and specific information on orthopedic and trauma surgical injuries or diseases.
Additional information URL: https://www.orthopy.de/instructions-for-use-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