Picterus® Jaundice Pro

Organization name

Picterus AS

SRN

NO-MF-000002136

Manufacturer status

Active

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

• CW999

  Do NOT use the app on newborns with: a. Jaundice appearing within the first 24 hours of life. b. Current or previous treatment involving phototherapy (light therapy) or prolonged exposure to sunlight because safety assessment for this patient group has not been performed. Light can alter the relationship between bilirubin levels in the blood and skin, affecting the accuracy of the result. c. A condition or treatment that affects skin color or appearance, excluding jaundice, such as skin diseases or extremely dry skin that appears cracked or peeled. The skin must be intact.

Primary placement in Norway; available across 16 countries total.

Trade name

Picterus® Jaundice Pro

UDI-DI code

07073087000082

Basic UDI-DI

707308701PicterusL6

Reference / catalog number

00028

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 Picterus® Jaundice Pro is intended to assist in screening and follow up of neonatal jaundice. Picterus® Jaundice Pro is a Software as a Medical Device (SaMD), it is an application for smartphones. The medical device is intended to support authorized healthcare providers, parents and/or caregivers (lay persons) of newborns in the assessment of neonatal jaundice. By using phones validated by Picterus AS, the Picterus® Calibration Card and installing the Picterus® Jaundice Pro app, one can screen newborns for neonatal jaundice in just minutes.

Additional information URL

https://picterus.com/picterus-jaundice-pro-instructions-for-use/

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.

• Z12080492NEONATOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Certificate health across this manufacturer's portfolio.