Organization name

Bracco Injeneering SA

SRN

CH-MF-000019387

Manufacturer status

Active

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

• Consult instructions for use

  read the operator manual before using the EmpowerCTA+ on a patient

Primary placement in Poland; available across 26 countries total.

Trade name

EmpowerCTA+ Injector System

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.

47630039302014

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.

B-47630039302014

Reference / catalog number

017285

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The EmpowerCTA+ Injector System is a low-pressure venous-side injector designed to deliver iodinated X-ray contrast media during CT procedures. The EmpowerCTA+ can deliver contrast media and saline.

Additional information URL

https://eifu.braccomedtech.com/

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.

• Z11039014MULTIPLE CONTRAST AGENT INJECTORS

• Class IIb medical devices in EUDAMED

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