MobiEye 720

Trade name

not provided

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.

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06903053081672

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.

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69449040AB060100015Y

Reference / catalog number

MobiEye 720

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.

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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.

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Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Mobile Radiography System

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• Z11031101MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  During X-ray radiography, use lead impregnated clothes, boards, or other dedicated protective devices to protect theSafety patient's sensitive parts (such as gonad), the operator, or the patient's helper.

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