Skip to content

Picterus AS

Norway NO-MF-000002136 Last updated 21 Oct 2026

Devices
3
Registries
EUDAMED
FDA recalls
0

Catalogue3

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 0297 1 certificate

  • 1000231881 Supplemented Expires in 2 days

    Quality management system EU MDR

    Issued
    14 Apr 2025
    Expires
    27 Oct 2026
    Reason
    Other

Notified bodies

  • Notified body 0297

About

Neonatal Jaundice Screening in the palm of your hand Picterus® Jaundice Pro
 100% detection of newborns in need of phototherapy Works on all skin tones 10,000+ newborns screened Endorsed by clinicians A fully certified medical app “As a NICU physician, I have fallen in love with Picterus Jaundice Pro for early screening and guiding diagnosis \[…\]

From the manufacturer's own website. Source

What Picterus AS makes

Picterus AS manufactures calibration tools, including the Picterus® Calibration Card, designed for verifying and maintaining the accuracy of medical imaging and diagnostic devices. The company also produces the Picterus® Jaundice Pro, a device intended for assessing jaundice levels in neonatal patients.

The company’s products are classified as Class I and Class IIa under EU regulations and are listed in the EUDAMED database. Picterus AS is based in Norway.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Picterus AS manufacture?

Picterus AS specializes in calibration tools and diagnostic devices. Their products include the Picterus® Calibration Card, which is used to verify and maintain the accuracy of medical imaging and diagnostic equipment, as well as the Picterus® Jaundice Pro, designed for assessing jaundice levels in newborns. These devices support precision in both imaging and neonatal care.

Where is Picterus AS based?

Picterus AS is headquartered in Norway. The company’s location in Norway aligns with its focus on developing high-quality medical devices tailored to global healthcare needs, particularly in calibration and neonatal diagnostics.

Which regulatory registries list Picterus AS’s devices?

Picterus AS’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This inclusion ensures transparency and compliance with EU regulatory requirements for devices classified under Class I and Class IIa.

How are Picterus AS’s devices classified under EU regulations?

Picterus AS’s devices are classified as either Class I or Class IIa under EU medical device regulations. Class I devices are generally low-risk and pose minimal risk to patients, while Class IIa devices involve a slightly higher risk, requiring additional scrutiny to ensure safety and performance. The classification depends on factors like the device’s intended use and potential health impact.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Norway
Address
61, Kjøpmannsgata, Trondheim, Norway
Phone
+47 40474893
PRRC contact
Alma Åslund
EUDAMED SRN
NO-MF-000002136