Regulatory

Product label

Product label version 1.2 (28 September 2026)

Date of issue: 2026-03-20 (web application); 2026-07-30 (iOS app added)

Device name

DR. INFO

Intended purpose

DR. INFO is intended to be used by healthcare professionals as a clinical reference and knowledge-support tool for supporting the practice of evidence-based medicine.

DR. INFO is designed as a clinical information and education platform for healthcare professionals, such as physicians, pharmacists, nurses and clinical researchers. It retrieves, displays, summarizes, and organizes authoritative sources such as medical guidelines, consensus statements, peer-reviewed literature, and public drug databases.

DR. INFO supports healthcare professionals in the process of clinical decision-making by providing access to and structured presentation of current, evidence-based medical information, such as guideline-recommended diagnostic and treatment pathways, for use in clinical practice. It retrieves EMA SmPC data for EU-approved medicines (e.g., indications, dosing, warnings) to assist clinicians in reviewing authorised product information relevant to patient management. It can generate source-referenced clinical visuals (e.g., hypertension management flow-chart) to aid patient education by the healthcare professional and interrogate specific documents (guidelines, SmPCs, consensus statements) at paragraph level with citation-anchored answers.

DR. INFO does not and may not be used to analyse personal health data of patients, rank or prioritize treatment options, provide diagnostic or therapeutic recommendations, calculate doses, or present outputs as action guidance at the point of care. All outputs are informational in nature and intended solely to assist qualified healthcare professionals in exercising their own clinical judgment.

Intended users

Healthcare professionals, such as physicians, pharmacists, nurses and clinical researchers. DR. INFO is not intended for use by patients or other lay persons.

Medical device information

CE-marked Class I medical device under Regulation (EU) 2017/745 on medical devices (MDR), classified under Annex VIII, Rule 11.

EMDN code: V92 — Medical device software

Manufacturer

Manufacturer

Synduct GmbH

Bergmannstr. 58, 80339 Munich, Germany

SRN (single registration number): DE-MF-000052647

Unique device identification (UDI)

Basic UDI-DI (web application and iOS app)
426258275DRINFOFF
UDI-DI — web application (DR. INFO)
04262582750018
UDI-DI — iOS app (DR. INFO AI)
04262582750025

Issuing entity: GS1

Warnings

  • This software provides clinical reference and knowledge support for healthcare professionals, including education; all outputs remain informational and require independent professional clinical judgment.
  • It does not provide clinical diagnosis, therapeutic recommendations or treatment directives.
  • All AI-generated summaries and visual abstracts must be independently verified by a qualified healthcare professional before any clinical action.
  • The software does not replace professional medical judgment.
  • Not intended for use by patients or other lay persons.
  • Not intended for emergency or time-critical clinical decisions.

Precautions

  • Do not enter patient data, including patient details without identifiers.
  • AI-generated summaries may contain summarisation errors. Check each statement against the cited source.
  • Review outputs with particular care when the question is asked in a language other than that of the source documents.
  • Do not copy unverified content into medical records or other systems.
  • A software or service failure can lead to incomplete or delayed answers. In that case, use other information sources.

Instructions for use

The instructions for use are provided in electronic form at Instructions for Use. A paper copy is provided free of charge on request at regulatory@synduct.com.

System requirements

  • Web application: Chrome 90+, Firefox 88+, Safari 14+ or Edge 90+; on mobile devices, iOS 15+ or Android 12+ browsers.
  • iOS app: iPhone or iPad with iOS 15.1 or later, from the Apple App Store.
  • An internet connection is required (cloud-based application).

Symbols

CE markMedical device (MD)

Contact and incident reporting

Safety and regulatory questions: regulatory@synduct.com. General questions: info@synduct.com.

Report any serious incident in connection with DR. INFO to Synduct at regulatory@synduct.com and to the competent authority of the Member State in which you are established (in Germany: the Federal Institute for Drugs and Medical Devices, BfArM).