MS1

Nom de l'organisation

Movesense Ltd

SRN

FI-MF-000024281

Statut du fabricant

Actif

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW011

  Movesense MD shall not be used as a primary monitoring device for vital physiological parameters (such as ECG, heart rate, respiratory rate) in clinical situations where the patient is in an immediate danger, such as during intensive care.
• CW010

  Movesense MD shall not be used as a life sustaining or life supporting device.
• CW018

  Movesense MD may not be used to measure ECG from infants weighing less than 10kg. There is no weight limit for the patients whose motion is measured.

Marché principal en Finlande ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

06429810883001

Basic UDI-DI

64298108830016K

Numéro de référence/catalogue

MS1

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Movesense MD sensor is a wearable and portable medical device and is intended for measuring single channel ambulatory ECG for the investigation of the human heart, and to provide precise quantitative measurement of human movement, enabling tracking of the effects of body condition, disease or injury through their influence on the movement system. Movesense MD provides an optional ECG R-peak detection and physiological parameter analysis of ECG data, such as HRV (Heart Rate Variability) and HR (Heart Rate). Device ECG functionality is intended to be used by home and professional users for patients with bodyweight of 10 kg or more, whereas the movement measurement functionality has no limitations. Device allows third party manufacturers to access and further process the measured data and data analyses via third party developed custom software, according to their intended purpose.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• C900399CARDIOVASCULAR SENSORS - OTHER

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel