One by Doc2U

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

One By Doc2U Kit

Model / Reference

ONEBDK

Primary DI / UDI-DI

03770022781047

Basic UDI-DI

3770022781ONEBDK4S

EMDN Code

V0399 Measurement devices - other

Device Class

Class IIa

Medical Purpose

Doc2U is a medical device for the measurement of vital constants such as blood pressure, temperature, oxygen saturation. The product can also capture video streams from precision cameras and audio streams from stethoscope-like subsystems. All these data are transmitted over a Wi-Fi type connectivity, allowing remote access in real or delayed time. This product is used in the context of medical teleconsultation (general or specialist) to obtain a diagnosis based on the product data. The consultation is conducted by the health professional, who has the measurements taken in real time, as well as the observations (audio or video). The product embeds 5 medical tools: -Stethoscope -Otoscope -Blood pressure monitoring -Oximeter -Thermometer The product is used by the patient in autonomy or assisted by a third party, not necessarily a healthcare professional. Assisted at a remote location by a healthcare professional in the case of teleconsultation, or in total autonomy for self-assisted monitoring. The product is not intended for use by patients in critical and/or life-threatening conditions.

EUDAMED SRN

FR-PR-000049577

• One by DOC2U

  Class IIa

  CE/MDR 21M00068SUP01 Expiring Valid to Oct 2027

• Tensioflash

  Class IIa

  CE/MDR 21M00068SUP01 Expiring Valid to Oct 2027

• One By Doc2U

  Class IIa

  CE/MDR