IscAlert Sensor

Organization name

SENSOCURE AS

SRN

NO-MF-000031688

Manufacturer status

Active

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

• CW009

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

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.

Primary placement in Norway; available across 1 country total.

Trade name

not provided

UDI-DI code

07090062320003

Basic UDI-DI

709006232ISCALERTSENSOR73

Reference / catalog number

IscAlert Sensor

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

IscAlertTM is a biomedical sensor system that measures the partial gas pressure of carbon dioxide (pCO2) in tissue local to sensor placement. Elevated pCO2 levels are associated with serious conditions such as hypoperfusion and ischemia. The IscAlert sensor system is intended for any medical condition, where there is an acute risk for local development of ischemia in tissue such as muscle and subcutaneous tissue, connective tissue or mucosal membranes, and a potential benefit of early detection and monitoring of ischemia.

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.

• V030204IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES
• V0399MEASUREMENT DEVICES - OTHER
• W0201040101BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)