M-HELI/2D

Organization name

Metaltronica SpA

SRN

IT-MF-000014684

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 11 countries total.

Trade name

not provided

UDI-DI code

08052405210050

Basic UDI-DI

805240521DIGITAL8H

Reference / catalog number

M-HELI/2D

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

HELIANTHUS is a medical device intended to produce digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for two-dimensional diagnosis, screening, three-dimensional tomosynthesis exams or for needle localization in case of biopsy.

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.

• Z11030202DIGITAL MAMMOGRAPHY SYSTEMS

Certificate health across this manufacturer's portfolio.