EMBP-1G-SB-EM

Nom de l'organisation

Empatica S.r.L.

SRN

IT-MF-000012905

Statut du fabricant

Actif

Santé des certificats sur le portefeuille de ce fabricant.

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

• CW274

  EUDAMED n'a pas publié de description pour ce code.
• CW014

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  Empatica cannot guarantee that EpiMonitor will detect every single seizure and deliver alerts accordingly. The product is not meant to substitute your current seizure monitoring practices, but rather to serve as a supplement in expediting first-response time. It is important not to alter or reduce seizure management practices when using EpiMonitor.
• CW999

  The product should not be used on unsupported OS or unsupported phones
• CW999

  No modification of the product is allowed. Modification of this product may cause interference with other devices and injury to the patient and user, including electric shock, burns, or death.
• CW999

  The battery is not a smart battery and cannot be removed for recharging. No attempt to repair or replace the battery is allowed. Modification of this product may cause interference with other devices and injury to the patient and user, including electric shock, burns, or death
• CW027

  MR-unsafe! Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core.
• CW999

  This device is contraindicated in patients with pacemakers and implantable cardioverter-defibrillators (ICDs). The product shall not be used with other magnetically susceptible medical devices. Do not operate the product while taking an X-ray or in hyperbaric chambers
• CW999

  Do not operate the device in close proximity (12 inches/30 cm) to portable RF communication equipment, including antennas, since they may interfere with device operation.

Marché principal en Irlande ; disponible dans 14 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

00853858006515

Basic UDI-DI

0853858006EpiDevWW

Numéro de référence/catalogue

EMBP-1G-SB-EM

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

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z121002NERVOUS SYSTEM MONITORING SYSTEMS