M-HELI/CMP

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 3 countries total.

Trade name

not provided

UDI-DI code

08052405210074

Basic UDI-DI

805240521DIGITAL8H

Reference / catalog number

M-HELI/CMP

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 C 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 and screening.

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.