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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

300-016 — Class IIa MDR by PARSYS TELEMEDECINE

MD Atlas
PARSYS TELEMEDECINE

EUDAMED last updated this device on Aug 31, 2022

300-016

3770028219300-01647

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PARSYS TELEMEDECINE
UDI-DI code: 03770028219001
Reference / catalog number: 300-016

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Manufacturer information

Organization name: PARSYS TELEMEDECINE
SRN: FR-MF-000011084
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 2022	Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770028219001
Basic UDI-DI: 3770028219300-01647
Reference / catalog number: 300-016
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: The Telemedicine Station S3 is a system contained in a hardcase, enabling the automatic and sequential capture and transmission of an oximetry sensor (SpO2) and a non-invasive pressure sensor (NIBP). It enables also the communication with various diagnostic devices, allowing to retrieve measurements data through USB or Bluetooth and transmit them. The data are collected on a central unit equipped with a touch screen that embeds a stand-alone software - MedCapture - allowing to organise measurements data with other information such as patient data, manual values or photo/video. The data can be transmitted for review to a remote recipient on a cloud platform, which can also support teleconsultation between the recipient and the S3 unit. The S3 in intended for professional and home-healthcare environments. The S3 is not intended for emergency environments.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1203020202TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS

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

300-016B-03770028219001On the market 25-001B-03770028219025On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.