Organization name

BMI Biomedical International S.r.l.

SRN

IT-MF-000017897

Manufacturer status

Active

+B705BHEC0W

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

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

• Consult instructions for use

Primary placement in Italy; available across 32 countries total.

Trade name

BHE-C

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.

+B705BHEC0W

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.

++B705RADSYSTEMKP

Reference / catalog number

BHEC001

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.

HIBCC

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

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

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

• Z110310MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY

• Class IIb medical devices in EUDAMED

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