BHEC001

Organization name

BMI Biomedical International S.r.l.

SRN

IT-MF-000017897

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 32 countries total.

Trade name

not provided

UDI-DI code

+B705BHEC0W

Basic UDI-DI

++B705RADSYSTEMKP

Reference / catalog number

BHEC001

Issuing entity

HIBCC

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Fixed Radiology Equipment, intended to acquire and provide images, used for diagnostic purposes. Mammographic, fluoroscopic and angiographic applications are excluded from the indications for use.The Medical devices are intended to capture radiographic images of human anatomy, from paediatric to geriatric patients. The devices are intended for use in general projection radiographic applications wherever conventional film systems, CR systems, or digital systems are employed. These analogue or digital radiographic medical devices are intended to be used by a qualified/trained radiologist or radiologic technologist on adult and paediatric subjects, for the acquisition of radiographic exposure images of the skull, spine, chest, pelvis, limbs, abdomen, extremities, and other body parts. The procedures may be performed with the patient seated, standing, or lying in prone or supine position.

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

+B705BHEC0W

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• Z110310MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY