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Organization name
UDI-DI code
Reference / catalog number

ONE BY DOC2U — Class IIa MDR by Doc2U

MD Atlas
Doc2U

EUDAMED last updated this device on Feb 20, 2025

ONE BY DOC2U

3770022781016W9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Doc2U
UDI-DI code: 03770022781009
Reference / catalog number: ONEBD

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Manufacturer information

Organization name: Doc2U
SRN: FR-MF-000022212
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 2023	Still on market
Spain	Jun 1, 2024	Aug 1, 2025

Device identification

Trade name: ONE BY DOC2U
UDI-DI code: 03770022781009
Basic UDI-DI: 3770022781016W9
Reference / catalog number: ONEBD
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product 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.
Additional information URL: https://www.doc2u.fr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0399MEASUREMENT DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Tensioflash3770022781860346AMOn the market

Certificates

Certificate health across this manufacturer's portfolio.

21M00068CRT01Issued
Quality management systemNotified body: 1912Expiry: Oct 24, 2027