IntelliProve

Organization name

IntelliProve

SRN

BE-MF-000037598

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Contra-indications: IntelliProve is not intended to be used by all individuals: - People with inked face (i.e. tattoos, ink). - People under the age of 18 years. - People with reduced blood flow in the face as IntelliProve will not be able to detect the significant intensity variations induced by the blood flow. - People with conditions causing tremors or the inability to hold their face still for at least 30 seconds (e.g. Parkinson or dementia) as, in this case, IntelliProve cannot perform an accurate health scan. - People that have a disability limiting them to perform the health scan according to the instructions for use. Warnings: - Do not perform health scans when the camera lens is unclean or broken. - Health scans can’t be performed without internet connection. - Do not perform health scans while driving or during (or immediately after) physical activity. - Do not use in poor lighting conditions. - Do not talk or move during the measurement. This can interrupt the health scan or influence the quality of the health scan. In both cases, the health scan will have to be performed again.

Primary placement in Belgium; available across 32 countries total.

Trade name

IntelliProve

UDI-DI code

05419980385406

Basic UDI-DI

54199803854IntellFQ

Reference / catalog number

Intell

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://docs.intelliprove.com/instructions-for-use

Clinical sizes

No clinical sizes registered for this device.

• Z129092VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.