MDoloris Medical Systems

Organization name

MDoloris Medical Systems SAS

SRN

FR-MF-000000421

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

Primary placement in France; available across 10 countries total.

Trade name

MDoloris Medical Systems

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

03760232460207

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

376023246ANI-SENSV2GE

Reference / catalog number

ART0074

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The electrodes are composed of a two-part device: a dual sensor and a single sensor connected together by an electrical thread. The sensor itself is divided into two areas. One part is an adhesive area and the other, the active area, is covered with conductive gel The principle of this two-part device is to place it on each side of the heart (thus on each side of the chest) to get a cardiac vector (the axis of the average cardiac vector according to the reference anatomical position is: forward, down and left).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

2 packaging levels registered — each level carries its own UDI-DI.

• 03760232460207× 1 unitBase unit
  • 03760232460191× 25 units
    • 03760232460214× 4 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• C020501ECG ELECTRODES

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.