smart medication eDiary

Organization name

smart medication eHealth Solutions GmbH

SRN

DE-MF-000007707

Manufacturer status

Active

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

• CW030

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

not provided

UDI-DI code

111739756233

Basic UDI-DI

B-111739756233

Reference / catalog number

smart medication eDiary

Issuing entity

IFA

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

smart medication eDiary supports people with hemophilia in their therapy management. smart medication eDiary is a digital substitution diary for people with hemophilia. The app is a multi-award winning electronic diary for optimized self-management in the daily management of a blood clotting disorder. The digital diary is registered as a medical device and can also be used by the patient independently of the attending physician to manage their own therapy. The application is free of charge, manufacturer-independent and can be used offline. It runs via the web browser and therefore does not need to be downloaded from the app stores. With the patient's consent, the documentation of the therapy can be made available directly to the treating physician. The high-quality long-term record is also suitable for supporting the long-term therapy goal of preventing joint bleeding. Patients can additionally select a pharmacy for the supply of factor preparations, which can then share information about the order and delivery status directly in the app. Similarly, estimated current factor levels can be accessed. With smart medication eDiary, all coagulation preparations from all manufacturers can be documented. The app is constantly being further developed based on current research results and in collaboration with hemostaseologists.

Additional information URL

https://www.smart-medication.eu/ediary

Clinical sizes

No clinical sizes registered for this device.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.