Organization name

Carbon Medical Technologies, Inc.

SRN

US-MF-000044355

Manufacturer status

Active

Primary placement in Italy; available across 32 countries total.

Trade name

BiomarC Secure Fiducial Marker

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.

10850002461005

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.

B-10850002461005

Reference / catalog number

040150

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.

GS1

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

BiomarC Secure Fiducial Marker

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.

• A019012BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS

• Class IIb medical devices in EUDAMED

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