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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

ANI Sensor V1 PLUS — Class I MDR by MDoloris Medical…

MD Atlas
MDoloris Medical Systems SAS

EUDAMED last updated this device on Feb 14, 2023

ANI Sensor V1 PLUS

376023246ANI-SENSV1PLUSEH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MDoloris Medical Systems SAS
UDI-DI code: 03760232460436
Reference / catalog number: ART0237

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Manufacturer information

Organization name: MDoloris Medical Systems SAS
SRN: FR-MF-000000421
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: ANI Sensor V1 PLUS
UDI-DI code: 03760232460436
Basic UDI-DI: 376023246ANI-SENSV1PLUSEH
Reference / catalog number: ART0237
Issuing entity: GS1

Classification

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

Device details

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.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

C020501ECG ELECTRODES

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

MDoloris Medical Systems376023246ANI-SENSV1GCOn the market MDoloris Medical Systems376023246ANI-SENSV2GEOn the market MDoloris Medical Systems376023246ANI-MR2XOn the market MDoloris Medical Systems376023246ANI-SENSV1PLUSEHOn 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.