Smart Care Plans

Organization name

Platform24 Healthcare AB

SRN

SE-MF-000026278

Manufacturer status

Active

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

• CW999

  Patients with life-threatening symptoms that require immediate medical attention, i.e. are expected to need acute hospitalization within 24 hours. In cases where these symptoms are discovered during the use of Smart Care Plans, the use of the device shall stop.
• CW999

  Patients who are not well-informed about their health condition, including but not limited to, recognizing signs of deterioration of their health condition and knowing when, where and how to seek emergency care if needed.
• CW999

  Patients with severe cognitive issues (including but not limited to dementia or severe intellectual disability)
• CW999

  Patients for which access to the required medical data for use of a smart digital care plan is restricted
• CW999

  Smart Care Plans is not intended to provide information which is used to take decisions with diagnosis or therapeutic purposes where such decisions have an impact that may cause death, irreversible deterioration of a person's state of health, serious deterioration of a person's state of health or a surgical intervention.

Primary placement in Sweden; available across 3 countries total.

Trade name

not provided

UDI-DI code

07350127221011

Basic UDI-DI

735012722P24002LT

Reference / catalog number

Smart Care Plans

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://platform24.com/manuals

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.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Certificate health across this manufacturer's portfolio.