Organization name

Sim&Cure

SRN

FR-MF-000000319

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• Sim&Size is not intended for diagnostic use or for recommending a specific treatment and is in no way intended to replace physician judgment.

  OTHER

• Sim&Size must be used with 3D rotational angiography (3DRA) medical imaging studies in DICOM format produced using the protocol for injecting contrast media supplied by the manufacturer when the scanner was installed.

  OTHER

• The results of the Sim&Size simulation reflect the state of the vessels and aneurysm(s) at the time point of imaging. As such: - In case of simulations performed with anterior medical images,results must be confirmed with medical images produced the day of the intervention, and - with images produced the day of intervention and in case vasodilators are used by the medical team, the arterial response of the patient can be a noticeable change in the vessel's caliber. Therefore, Sim&Size must be used with medical imaging studies acquired after the patient's response to the vasodilators has stabilized.

  OTHER

• Sim&Size user(s) must receive training from Sim&Cure before using the Sim&Size MD in routine clinical use.

  OTHER

Primary placement in Austria; available across 25 countries total.

Trade name

Sim&Size

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.

03665786000018

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.

3665786S&SV323

Reference / catalog number

2.1

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.

• Z11030592RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Class IIa medical devices in EUDAMED

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