Euroampli Alien Cardio - Vers. 2121

Organization name

eurocolumbus s.r.l.

SRN

IT-MF-000016861

Manufacturer status

Active

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

• CW007

  EUDAMED did not publish a description for this code.
• CW016

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

08055715530122

Basic UDI-DI

B-08055715530122

Reference / catalog number

Euroampli Alien Cardio - Vers. 2121

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Euroampli Alien Cardio is an interventional radiology device with fluoroscopy functions, designed for use during image-guided procedures, primarily in the cardiovascular field for electrophysiology, hemodynamics, and DSA, but also in gastroenterology, neurology, orthopedics, urology, vascular applications, and pediatrics. The device is a mobile unit equipped with a motor-assisted isocentric C-arm for all movements and a high thermal capacity, liquid-cooled X-ray tube housing. Patient data and radiological image acquisition, processing, and management are handled by the proprietary Eurocolumbus FLY software.

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.

• Z11030101MOBILE ANGIOGRAPHY SYSTEMS FOR ANGIOPLASTY AND CATHETERIZATION
• Z11039017MOBILE RADIOSCOPIC UNITS