Picterus AS
Norway NO-MF-000002136 Last updated 21 Oct 2026
- Devices
- 3
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Picterus® Calibration Card Ref 00763
Picterus® Calibration Card Ref 07073087007623
Picterus® Jaundice Pro Ref 00028
EUDAMED certificates
Notified body 0297 1 certificate
- 1000231881 Supplemented
Quality management system EU MDR
- Issued
- 14 Apr 2025
- Expires
- 27 Oct 2026
- Reason
- Other
Related companies
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 \[…\]
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.
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.
Information
- Country
- Norway
- Address
- 61, Kjøpmannsgata, Trondheim, Norway
- Website
- www.picterus.com/
- linkedin.com/company/picterus-as
- facebook.com/picterus
- [email protected]
- Phone
- +47 40474893
- PRRC contact
- Alma Åslund
- EUDAMED SRN
- NO-MF-000002136