EMBP-1G-SB-EM

Organization name

Empatica S.r.L.

SRN

IT-MF-000012905

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW274

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this 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.

Primary placement in Ireland; available across 14 countries total.

Trade name

not provided

UDI-DI code

00853858006515

Basic UDI-DI

0853858006EpiDevWW

Reference / catalog number

EMBP-1G-SB-EM

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• Z121002NERVOUS SYSTEM MONITORING SYSTEMS