GMILOU

Organization name

General Medical Italia LTD Swiss Branch

SRN

CH-MF-000030023

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW028

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 3 countries total.

Trade name

not provided

UDI-DI code

07649996713032

Basic UDI-DI

7649996713Lucerna-UA-FaV9

Reference / catalog number

GMILOU

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The device is used to convert an X-ray image into a visible image to reveal the anatomical structure. The system can be used for fluoroscopy of the chest and lungs, as well as for fluoroscopy of the abdomen, and can be used to expose the bones and soft tissues of various parts of the body with a photographic function to meet the Radiology Department for outpatient examinations and emergency examinations: - Single acquisition, and continuous point - Digital photography - Whole-body splicing (optional) - Digital Fluoroscopy The Lucerna U-Arm family includes the following variants, distinguished by the specific combination of integrated main components: • Lucerna U-Arm S • Lucerna U-Arm 3D • Lucerna U-Arm DR 65 • Lucerna U-Arm DR 65C

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11031101MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.