Eu Mdr Eu Md Class 2a On The Market 🇫🇷 France

ONE BY DOC2U

Doc2U · 🇫🇷 France
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0

Basic Information

Primary DI
03770022781009
Basic UDI-DI Code
3770022781016W9
Reference
ONEBD
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
Doc2U

Additional Description

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 a 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.

CND Nomenclature Codes

Code Description
V0399 MEASUREMENT DEVICES - OTHER

Available In Countries

🇪🇸 Spain 🇫🇷 France

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