Duodecim Calculators and Forms (EBMEDS®)
EBMEDS® Calculators and Forms is a medical device, class IIa, according to the EU MDR 2017/745.The manufacturer is Duodecim Publishing Company Ltd.
Address: Kaivokatu 8, 00101 Helsinki
Version information: EBMEDS 4.0.3 Master Data 3.0.3
UDI-information: UDI 06429810586025(8012)EBMEDS v4.0.3
Use by date: 2 years from the manufacture
Date of manufacture:2/2025
<Intended Use
EBMEDS® Calculators and Forms is a medical device, which can be used to calculate certain clinical formulas used in daily clinical practice. Some of the calculators are also suitable for non-professionals (ISO-BMI, Finrisk). In non-professional use the calculators are intended for generic follow-up of personal wellbeing, and not for clinical use. Each calculator comes with further information about its use, suitability for different patients, and possible limitations.
Limitation of Liability
The results provided by calculators and forms must never be used to directly determine the treatment of an individual patient. The calculators are based on statistical models, and they do not substitute the judgement of a clinician who knows the patient and manages the treatment plan. The patient’s personal medical history and clinician’s experience, knowledge and training need to be considered in decision-making. Clinicians should discuss with the patients about the calculator results, predictions and treatment decisions.
The user must use precaution when interpreting the results. Each calculator and form have been tested carefully, but logical and programming errors are still possible. The user also must consider the possible calculator and form specific limitations and suitability for the subject. The pre-filled or directly entered data in the calculator or form may be incorrect, which may cause misleading results.
The ultimate responsibility for all decisions affecting the medical care of the patient rests with the healthcare professionals in charge of the treatment. The content targeted for non-professionals is not intended for clinical decision-making, it is only for generic follow-up of personal wellbeing. EBMEDS® Calculators and Forms does not impose treatment decisions or supersede proper medical judgement by a health care professional; it is merely a source of information for them as they perform their work. Duodecim Publishing Company Ltd. or its distributor does not take responsibility for the decisions made in patient care.