DeltaScan Monitor

Organization name

Prolira BV

SRN

NL-MF-000000253

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 3 countries total.

Trade name

DeltaScan Monitor

UDI-DI code

08719326465395

Basic UDI-DI

87193264653006.000P7

Reference / catalog number

006.000.A

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

The DeltaScan Monitor is intended to support the clinical assessment of acute encephalopathy and delirium by providing a DeltaScan Score based on electroencephalography (EEG) signals. The DeltaScan Score, which is the DeltaScan Monitor detection and monitoring parameter, may be used as an aid in the diagnosis of the state of a patient’s acute encephalopathy or delirium.

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.

• Z12100302ELECTROENCEPHALOGRAPHS

Certificate health across this manufacturer's portfolio.