Organization name

Empatica S.r.L.

SRN

IT-MF-000012905

Manufacturer status

Active

Primary placement in Ireland; available across 14 countries total.

Trade name

EpiMonitor by Empatica

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.

00853858006379

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.

0853858006EpiAppX4

Reference / catalog number

EpiMonitor-IOS

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.

• Z121002NERVOUS SYSTEM MONITORING SYSTEMS

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.