Organization name

IONIC HEALTH TECHNOLOGIES S.A.

SRN

BR-MF-000039811

Manufacturer status

Active

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

• Consult instructions for use
• Caution

Primary placement in Portugal; available across 25 countries total.

Trade name

nCommand Lite

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.

07898974112002

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.

7898974112NCLITE2L

Reference / catalog number

nCommand Lite

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.ionic.health/nclite

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.

• Z119082VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES

• Class IIb medical devices in EUDAMED

This device is not currently linked to any other device.

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