EmbracePlus

Organization name

Empatica S.r.L.

SRN

IT-MF-000012905

Manufacturer status

Active

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

• Non-ionizing electromagnetic radiation
• Type BF applied part
• The product should not be used on unsupported OS or unsupported phones

  OTHER

• 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

  OTHER

• 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

  OTHER

• MR UNSAFE

  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.

• 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.

  OTHER

Primary placement in Italy; available across 12 countries total.

Trade name

EmbracePlus

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.

00853858006232

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.

0853858006EMBRACEPLUS44

Reference / catalog number

EMBP-CC-MS

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 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.

• Z1203020601COMPLETE VITAL SIGNS TELEMETRY SYSTEMS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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