Healthentia v4

Organization name

INNOVATION SPRINT SRL

SRN

BE-MF-000000879

Manufacturer status

Active

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

• CW999

  CONTRA-INDICATIONS: • Healthentia is not intended for the monitoring of patients in critical situations (operating room, emergency, intensive care). • Any physical or cognitive condition that, in clinical judgment, would prevent the patient from using Healthentia, e.g. dementia. • The device should not be used during pregnancy. • Healthentia has not been tested with pediatric population. Therefore, Healthentia is intended for adult use only (>18 years old) and does not cover use by children. • The device is not intended to replace the care of a health care professional, including prescription, diagnosis or treatment. • Consult periodically the Alerts dashboard as it may influence the follow-up of your patients. • The user is responsible of the final assessment of the diagnosis and treatment decided for the patient. • The device providing information to support diagnostic and therapeutic decision, but the overall clinical context should be taken into consideration before taking any decision.
• CW999

  WARNINGS: • The device is not intended to replace the care of a health care professional, including prescription, diagnosis or treatment. • Consult periodically the Alerts dashboard as it may influence the follow-up of your patients. • Healthentia is not monitored in real time by healthcare personnel; it is intended for non-emergency communication only. In case of an emergency, contact your care unit or the emergency number by phone. • In some special cases, the self-care advice and instructions provided by Healthentia may not be applicable to your situation. • If you have questions about your care, symptoms and management, contact your healthcare team. • The device is not intended to replace the care of a healthcare professional, including prescription, diagnosis or treatment. • Telemonitoring does not replace regular check-ups with your doctor. Consult your doctor in case of severe and persistent symptoms. • In combination with Healthentia, use only measuring devices for which the technical performances (accuracy, precision) have been verified by your healthcare provider as it may affect the outcome of your monitoring. • Verify the consistency of your clinical data and the good transfer of them to your healthcare provider as the quality of the diagnosis and treatment is partially based on this information.
• CW999

  DISCLAIMER: • The user is responsible of the final assessment of the diagnosis and treatment decided for the patient. • The device providing information to support diagnostic and therapeutic decision, but the overall clinical context should be taken into consideration before taking any decision. • Your healthcare provider is responsible of the final assessment of your diagnosis and treatment. • Healthentia is providing information to support diagnostic and therapeutic decision, but the overall clinical context should be taken into consideration before taking any decision.

Primary placement in Belgium; available across 12 countries total.

Trade name

not provided

UDI-DI code

05419980178930

Basic UDI-DI

54199801789HLTv4GY

Reference / catalog number

Healthentia v4

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://healthentia.com/

Clinical sizes

No clinical sizes registered for this device.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

This device is not currently linked to any other device.

Certificate health across this manufacturer's portfolio.