inHEART Models AI

Organization name

inHEART

SRN

FR-MF-000006723

Manufacturer status

Active

Primary placement in France; available across 11 countries total.

Trade name

inHEART Models AI

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.

03770019599167

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.

3770019599AIv16J

Reference / catalog number

v3

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

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.

• Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Class IIa medical devices in EUDAMED

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